FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 2864505
·
Received November 9, 2012
Report
- Report Number
- 1831750-2012-11715
- Event Type
- Malfunction
- Date Received
- November 9, 2012
- Date of Event
- October 16, 2012
- Report Date
- October 16, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: LOAD CELLS. CONCLUSION: REPLACEMENT PARTS ON ORDER. ACCOUNT WILL REPLACE UPON RECEIPT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SCALE WAS INACCURATE. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS ANY PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOBED II | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | FL28EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |