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Medline
MEDLINE INDUSTRIES, INC. · Model MDSPHY100 · UDI-DI 10888277635005
MLN
Prescription
0
510(k) clearances
1,347
Adverse events (194 deaths)
9
Recalls
21
Facilities
Description
PAD, DEFIB, ADULT, RADIOLUCENT, PHYSIO
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-03-31 | ConMed Corporation | The specific lot was assembled without the rivet cover. |
| 2010-12-17 | Heart Sync, Inc | The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until i |
| 2010-12-17 | Heart Sync, Inc | The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until i |
| 2008-12-05 | Heart Sync, Inc | The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. |
| 2008-12-05 | Heart Sync, Inc | The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. |
| 2008-06-16 | Bio-Detek, Inc. | Multi-function electrode programmed as a Pediatric instead of Adult |
| 2007-03-08 | Conmed Corporation | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and |
| 2007-03-08 | Conmed Corporation | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product unusable. The Zoll and |
| 2005-11-18 | Philips Medical Systems | The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector |
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Get your free API keyRead the docsData 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.