FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 1212704
·
Received October 22, 2008
Report
- Report Number
- 1056128-2008-00077
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- September 25, 2008
- Report Date
- October 22, 2008
- Manufacturer
- ASCENT HEALTHCARE SOLUTIONS
- Product Code
- KCY
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FOUND TO HAVE SEPARATION AT THE TUBE-TO-PORT JUNCTIONS. FUNCTION TESTING WAS PERFORMED AND THE DEVICE FAILED INFLATION TESTING.
Description of Event or Problem · 1
THE TOURNIQUET CUFF SHOWED SIGNS OF LEAKING WHILE BEING USED. THE DEVICE WAS REPLACED WITH ANOTHER TOURNIQUET CUFF AND NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | KCY (REPROCESSED) | KCY | ASCENT HEALTHCARE SOLUTIONS | 60-7075-106 | 154786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |