FDA Adverse Event
Malfunction
Summary report: N
INFINITY VISTA
MDR report key: 981208
·
Received January 11, 2008
Report
- Report Number
- 1220063-2008-00002
- Event Type
- Malfunction
- Date Received
- January 11, 2008
- Date of Event
- December 14, 2007
- Report Date
- January 8, 2008
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE HAVE REQUESTED THE RETURN OF THE MONITOR AND BATTERY FOR EVALUATION. RESULTS WILL BE INCLUDED IN A FOLLOW UP REPORT.
Description of Event or Problem · 1
DRAEGER MEDICAL SYSTEMS INC HAS RECEIVED INFO FROM A CUSTOMER THAT A SHORT CIRCUIT OF THE INTERNAL LEAD ACID BATTERY WAS FOUND DURING A ROUTINE MAINTENANCE ACTIVITY OF OUR VISTA PT MONITOR. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFINITY VISTA | BEDSIDE PATIENT MONITOR | MHX | DRAEGER MEDICAL SYSTEMS, INC. (IT/M) | MS14742 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |