FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 2092337
·
Received May 3, 2011
Report
- Report Number
- 1831750-2011-04269
- Event Type
- Malfunction
- Date Received
- May 3, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
SCALE OUT OF CALIBRATION.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED ALARM KEPT GOING OFF AND THE SCALE READING WAS INACCURATE. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH ZU | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | 2141 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |