FDA Adverse Event
Malfunction
Summary report: N
6000CMS IOD
MDR report key: 3221680
·
Received June 17, 2013
Report
- Report Number
- 1722139-2013-01937
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- January 13, 2011
- Report Date
- March 17, 2011
- Manufacturer
- MOOG DEVICE GROUP
- Product Code
- FRN
- PMA / PMN Number
- K981816
- Removal / Correction Number
- Z-1868-2011
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NEW PUMP SOFTWARE WAS INSTALLED. REFERENCE RECALL NUMBER Z-1868-2011.
Description of Event or Problem · 1
INFORMATION RECEIVED STATES THAT PUMP HAD EXPERIENCED ERROR CODE 36.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273083 | 6000CMS IOD | FRN | MOOG DEVICE GROUP | 6000CMS IOD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |