FDA Adverse Event
Malfunction
Summary report: N
GOBED II MED/SURG BED
MDR report key: 3170845
·
Received June 14, 2013
Report
- Report Number
- 0001831750-2013-05451
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 20, 2013
- Report Date
- May 20, 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
FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS. FURTHER INVESTIGATION DETERMINED THERE WAS AN ISSUE WITH THE SCALE BEING INACCURATE AND NOT THE POWER CORD AS INITIALLY REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED BY REPAIR WORK ORDER THAT THE SCALE WAS INACCURATE DUE TO A FAULTY LOAD CELLS. 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 BY REPAIR WORK ORDER THAT THE POWER CORD HAD TO BE REPLACED. 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 |
|---|---|---|---|---|---|---|---|
| 272228 | GOBED II MED/SURG BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |