FDA Adverse Event
Malfunction
Summary report: N
SECURE ACUTE CARE BED 3/01
MDR report key: 2962175
·
Received February 14, 2013
Report
- Report Number
- 0001831750-2013-01171
- Event Type
- Malfunction
- Date Received
- February 14, 2013
- Date of Event
- January 22, 2013
- Report Date
- January 22, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW UP BEING SUBMITTED TO REFLECT THE ISSUE OF THE SHEATHING BEING DAMAGED ON THE POWER CORD.
Additional Manufacturer Narrative · 1
RESULT- SIDERAIL TIMING LINK, MOTION INTERRUPT PAN.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE PATIENT LEFT SIDERAIL WOULD NOT LOCK AND THE MOTION INTERRUPT PAN WAS MISSING.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE PATIENT LEFT SIDERAIL WOULD NOT LOCK AND THE MOTION INTERRUPT PAN WAS MISSING. IT WAS ALSO REPORTED THAT THE SHEATHING ON THE POWER CORD WAS DAMAGED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCES OR CLINICALLY RELEVANT DELAYS IN TREATMENT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65963 | SECURE ACUTE CARE BED 3/01 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |