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TigerConnect Alarm Management
Critical Alert · UDI-DI 00860006582012
1
510(k) clearances
325
Adverse events (98 deaths)
23
Recalls
73
Facilities
Description
TigerConnect (TC) Alarm Management is a software as a medical device (SaMD) capable of acquiring alarms, events, and parameters from healthcare systems, and intelligently forwarding this information as secondary notifications to designated commercial endpoint devices. The endpoint devices act as non-regulated medical device data system (MDDS) devices that display the information from TC Alarm Management. TC Alarm Management is intended for use as a secondary alarm; it does not replace the alarm function on the primary device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2026-08-31 | Mindray DS USA, Inc. | Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions |
| 2025-11-18 | Mindray DS USA, Inc. dba Mindray North America | When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing. |
| 2024-02-28 | Philips North America | It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode. |
| 2022-01-03 | Philips North America Llc | eCareManager (eCM) Sentry Score software not approved for use |
| 2021-05-27 | Mindray DS USA, Inc. dba Mindray North America | Telepack may not power on when using the 3AA battery cradle. |
| 2021-02-22 | Mindray DS USA, Inc. dba Mindray North America | BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no |
| 2018-01-17 | Spacelabs Healthcare Inc | Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring. |
| 2017-09-28 | Philips Electronics North America Corporation | Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram |
| 2017-07-14 | Mindray DS USA, Inc. dba Mindray North America | A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate. |
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