FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN_MEDICAL_PRODUCT
MDR report key: 3023455
·
Received March 27, 2013
Report
- Report Number
- 0001831750-2013-02590
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 5, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPLACEMENT PARTS SENT TO ACCOUNT TO COMPLETE REPAIR.
Additional Manufacturer Narrative · 1
FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS.
Description of Event or Problem · 1
IT WAS REPORTED BY REPAIR WORK ORDER THAT THE SCALE WAS INACCURATE DUE TO MALFUNCTIONING LOAD CELLS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAYS IN TREATMENT WERE REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED BY REPAIR WORK ORDER THAT THE SCALE WAS INACCURATE DUE TO MALFUNCTIONING LOAD CELLS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAYS IN TREATMENT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125404 | UNKNOWN_MEDICAL_PRODUCT | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |