FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR STRETCHER
MDR report key: 3896802
·
Received May 20, 2014
Report
- Report Number
- 3006697241-2014-00471
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- April 24, 2014
- Report Date
- April 24, 2014
- Manufacturer
- HILLROM DE MEXICO S DE RL DE CV
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE HEAD END BRAKE ADJUSTERS WERE WORN. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED FROM 2010-2011 AND 2013-2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECHNICIAN STATING THE BRAKES WERE NOT HOLDING. THE BED WAS LOCATED IN THE ER AT THE ACCOUNT. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300628 | TRANSTAR STRETCHER | WHEELED STRETCHER | FPO | HILLROM DE MEXICO S DE RL DE CV | 8000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |