FDA Adverse Event
Malfunction
Summary report: N
MULTI GAS MGM+
MDR report key: 518483
·
Received March 31, 2004
Report
- Report Number
- 9611500-2004-00006
- Event Type
- Malfunction
- Date Received
- March 31, 2004
- Date of Event
- March 11, 2004
- Report Date
- March 31, 2004
- Manufacturer
- DR`A'GER MEDICAL AG & CO. KGAA
- Product Code
- CCK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A MGM GAS MEASUREMENT UNIT HAD REGISTERED A HARDWARE FAILURE AND DID NOT DISPLAY THE CO2 READING. THREE CROSSES WERE DISPLAYED WHERE NORMALLY THERE WOULD BE A CO2% READING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI GAS MGM+ | GAS ANALYSER | CCK | DR`A'GER MEDICAL AG & CO. KGAA | MULTI GAS MGM+I | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |