FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH EC MARK
MDR report key: 2800242
·
Received October 8, 2012
Report
- Report Number
- 1831750-2012-10541
- Event Type
- Malfunction
- Date Received
- October 8, 2012
- Date of Event
- September 11, 2012
- Report Date
- September 11, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: HARNESS CABLE #2 HAD TO BE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BED WOULD NOT LOWER CORRECTLY. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH EC MARK | A/C HOSP BED | FNL | STRYKER MEDICAL | 2130 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |