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EMI

XIAMEN COMPOWER MEDICAL TECH. CO., LTD · Model CP641000+2A+PG · UDI-DI 06946430414366

OEV Prescription

510(k) clearances

197

Adverse events (19 deaths)

Recalls

Facilities

Description

The cardiopulmonary resuscitation aid kit comprises of one CPR mask with Oxygen Port, two pieces alcohol pads and one pair PVC glove. This kit is designed for mouth to mask ventilation to health emergency patients requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing patient. It functions as a barrier to direct expired air from the patient away from the user. It can be used with supplemental oxygen when needed.

Recalls

Date	Firm	Reason
2020-05-19	ROi CPS LLC	Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit
2017-04-27	Vyaire Medical	The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab
2017-04-27	Vyaire Medical	The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab
2017-04-27	Vyaire Medical	The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab
2017-04-27	Vyaire Medical	The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab
2017-04-27	Vyaire Medical	The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab
2017-04-27	Vyaire Medical	The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab
2017-04-27	Vyaire Medical	The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab
2017-04-27	Vyaire Medical	The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab
2017-04-27	Vyaire Medical	The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unab

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.