FDA Adverse Event
Malfunction
Summary report: N
RENASYS EZ PLUS
MDR report key: 3952694
·
Received July 23, 2014
Report
- Report Number
- 3006760724-2014-00398
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- April 7, 2014
- Report Date
- July 22, 2014
- Manufacturer
- SMITH & NEPHEW WOUND MANAGEMENT
- Product Code
- OMP
- PMA / PMN Number
- K102001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED FOR EVALUATION, AND SERIAL NUMBER WAS NOT PROVIDED. NO EVALUATION POSSIBLE.
Additional Manufacturer Narrative · 1
ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENT REPORT.
Description of Event or Problem · 1
FAILURE TO ALARM. NEGATIVE PRESSURE WOUND THERAPY MACHINE ALARM FAILURE OCCURRED. THE DRESSING WAS NOT INTACT AND THE UNIT WAS NOT ALARMING. DRAINAGE WAS VISIBLE THROUGH THE DRESSING AND LEAKING DOWN THE LEG OF THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431602 | RENASYS EZ PLUS | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP | OMP | SMITH & NEPHEW WOUND MANAGEMENT | 66800697 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |