FDA Adverse Event
Malfunction
Summary report: N
M3000
MDR report key: 2276192
·
Received September 8, 2011
Report
- Report Number
- 1220063-2011-00040
- Event Type
- Malfunction
- Date Received
- September 8, 2011
- Date of Event
- August 8, 2011
- Report Date
- August 12, 2011
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
- Product Code
- MHX
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE ACTIVELY MONITORING A PT, THIS M3000 APPEARED TO DISCHARGE THE PT WITHOUT USER INTERVENTION AND THE ASSOCIATED ICS DISPLAYED A 'BED DISCONNECTED' MESSAGE FOR THE BED. THERE WAS NO PT INJURY REPORTED. DRAEGER REFERENCE NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M3000 | PATIENT MONITOR | MHX | DRAEGER MEDICAL SYSTEMS, INC. (IT/M) | MS26076 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | NO |