FDA Adverse Event
Injury
Summary report: N
SOLAR 8000M
MDR report key: 1970490
·
Received January 20, 2011
Report
- Report Number
- 2124823-2011-00004
- Event Type
- Injury
- Date Received
- January 20, 2011
- Date of Event
- December 22, 2010
- Manufacturer
- GE HEALTHCARE
- Product Code
- MHX
- PMA / PMN Number
- K012467
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A SITE REPORTED THAT A PT EXPERIENCED AN ASYSTOLE EVENT, BUT THE MONITOR DID NOT PROVIDE AN ASYSTOLE ALARM. INSTEAD THE MONITOR PROVIDED "BRADY" (BRADYCARDIA) AND "IRREGULAR" ALARMS. PER THE NURSE MANAGER OF THE UNIT THE PT WAS FOUND SLUMPED OVER IN A CHAIR AND REQUIRED TREATMENT. THE PT REPORTEDLY REGAINED A HEART RATE AND SURVIVED THE EVENT. AN INITIAL EVALUATION OF THE LOG FILES WAS COMPLETED. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLAR 8000M | PHYSIOLOGICAL PT MONITOR | MHX | GE HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Life Threatening| O| R |