FDA Adverse Event
Malfunction
Summary report: N
CAPITAL BLOOD/FLUID WARMER
MDR report key: 4269031
·
Received November 21, 2014
Report
- Report Number
- 0001831750-2014-03372
- Event Type
- Malfunction
- Date Received
- November 21, 2014
- Date of Event
- November 18, 2014
- Report Date
- November 18, 2014
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- KZL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE UNIT IS NOT REPAIRABLE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE UNIT HAD CURRENT LEAKAGE ABOVE SPECIFICATION. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756419 | CAPITAL BLOOD/FLUID WARMER | DEVICE, WARMING. BLOOD AND PLASMA | KZL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |