FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN_MEDICAL_PRODUCT
MDR report key: 2990641
·
Received March 5, 2013
Report
- Report Number
- 0001831750-2013-01756
- Event Type
- Malfunction
- Date Received
- March 5, 2013
- Date of Event
- February 7, 2013
- Report Date
- February 7, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP SUBMITTED AS THIS COMPLAINT WAS PREVIOUSLY REPORTED IN MEDWATCH #0001831750-2013-01750.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT A COMPONENT BURNED ON THE MOTOR CONTROL BOARD. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT A COMPONENT BURNED ON THE MOTOR CONTROL BOARD. 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 |
|---|---|---|---|---|---|---|---|
| 94290 | UNKNOWN_MEDICAL_PRODUCT | UNKNOWN | UNK | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |