FDA Adverse Event
Malfunction
Summary report: N
PERFUSOR SPACE
MDR report key: 3233284
·
Received July 12, 2013
Report
- Report Number
- 9610825-2013-00174
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Manufacturer
- B. BRAUN MELSUNGEN AG
- Product Code
- FRN
- PMA / PMN Number
- K062699
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
(B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). (B)(4). THE ACTUAL DEVICE HAS BEEN RECEIVED AND THE EVAL ON GOING AT THIS TIME. A F/U REPORT WILL BE PROVIDED WHEN THE EVAL IS FINISHED AND THE RESULTS BECOME AVAILABLE.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323689 | PERFUSOR SPACE | VOLUMETRIC PUMP | FRN | B. BRAUN MELSUNGEN AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |