FDA Adverse Event
Death
Summary report: N
MX40 4.4 GHZ SMART HOPPING
MDR report key: 4224077
·
Received October 31, 2014
Report
- Report Number
- 1218950-2014-06495
- Event Type
- Death
- Date Received
- October 31, 2014
- Date of Event
- October 3, 2014
- Report Date
- October 4, 2014
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- DSI
- PMA / PMN Number
- K113125
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4): A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PATIENT WAS BEING MONITORED WITH A PHILIPS MX40 TELEMETRY DEVICE. REPORTEDLY, THE BATTERY IN THE CORRESPONDING DEVICE WAS FULLY DEPLETED WHILE THE PATIENT WAS REGISTERING RED ALARMS ON THE MONITOR. THE BATTERIES WERE REPLACED; HOWEVER, THE NURSING STAFF SOON REALIZED THAT THE CENTRAL STATION WAS NOT RECEIVING A SIGNAL FROM THE TELEMETRY DEVICE. THE PATIENT WAS FOUND TO BE UNRESPONSIVE WHEN THE USER WENT TO CHECK THE DEVICE. THE PATIENT EXPIRED SEVERAL DAYS LATER AFTER BEING TAKEN OFF LIFE SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 699993 | MX40 4.4 GHZ SMART HOPPING | DETECTOR AND ALARM, ARRHYTHMIA | DSI | PHILIPS MEDICAL SYSTEMS | 865350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Death |