FDA Adverse Event
Death
Summary report: N
PHILIPS MEDICAL SYSTEMS
MDR report key: 18948899
·
Received March 20, 2024
Report
- Report Number
- MW5153018
- Event Type
- Death
- Date Received
- March 20, 2024
- Date of Event
- February 13, 2024
- Report Date
- March 15, 2024
- Manufacturer
- PHILIPS NORTH AMERICA LLC.
- Product Code
- MHX
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PT ON PHILIPS MX40-1C4 TELEMETRY MONITOR. UNCLEAR IF MONITOR WAS CAPTURING FROM 23:59 - 02:22 ON (B)(6) 2024. PT FOUND IN FULL ARREST AND RESUSCITATION UNSUCCESSFUL. UNK AT THIS TIME IF IT IS USER OR DEVICE ERROR CONTRIBUTED TO THE OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 524073 | PHILIPS MEDICAL SYSTEMS | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | MHX | PHILIPS NORTH AMERICA LLC. | MX40-1C4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Death |