FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH EU
MDR report key: 2224201
·
Received July 15, 2011
Report
- Report Number
- 1831750-2011-07143
- Event Type
- Malfunction
- Date Received
- July 15, 2011
- Date of Event
- June 17, 2011
- Report Date
- June 17, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ANGLE OUT-OF-CALIBRATION.
Description of Event or Problem · 1
IT HAS BEEN REPORTED BY SERVICE REPORT THAT THE BED IS GIVING AN INCORRECT ANGLE MEASUREMENT. NO P INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH EU | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | 2131 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |