FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN
MDR report key: 1823275
·
Received August 27, 2010
Report
- Report Number
- 1831750-2010-01929
- Event Type
- Malfunction
- Date Received
- August 27, 2010
- Date of Event
- August 2, 2010
- Report Date
- August 2, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIV.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCORRECT SERVICE PART COMPONENT WAS SHIPPED TO THE DISTRIBUTOR.
Description of Event or Problem · 1
THE DISTRIBUTOR (B)(4) IN (B)(4) REPORTED THAT THE MOTOR REC'D IS WITH INCORRECT VOLTAGE (115VOLTS INSTEAD OF 220VOLTS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | A/C POWERED HOSPITAL BED | FNL | STRYKER CORP., MEDICAL DIV. | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |