FDA Adverse Event
Malfunction
Summary report: N
RENASYS GO PUMP SALE
MDR report key: 5148158
·
Received October 14, 2015
Report
- Report Number
- 3006760724-2015-00095
- Event Type
- Malfunction
- Date Received
- October 14, 2015
- Date of Event
- October 8, 2015
- Report Date
- October 9, 2015
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- OMP
- PMA / PMN Number
- K083375
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SMITH & NEPHEW, INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW, INC., WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE FAILED TO SOUND THE ALARM DESPITE THE AIR LEAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 680599 | RENASYS GO PUMP SALE | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP | OMP | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |