FDA Adverse Event
Malfunction
Summary report: N
PROCEDURAL TRANSTAR STRETCHER
MDR report key: 3932258
·
Received April 4, 2014
Report
- Report Number
- 3006697241-2014-00311
- Event Type
- Malfunction
- Date Received
- April 4, 2014
- Date of Event
- March 7, 2014
- Report Date
- March 7, 2014
- Manufacturer
- HILLROM DE MEXICO S DE RL DE CV
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND THE BRAKES WERE LOOSE BECAUSE THE I-BOLT ON THE ROD END OF THE BRAKES NEEDED ADJUSTMENT. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN ADJUSTED THE I-BOLT ON THE BRAKE ROD END TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BRAKES WERE NOT HOLDING TIGHTLY. THE BED WAS LOCATED IN THE BED SHOP AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205333 | PROCEDURAL TRANSTAR STRETCHER | WHEELED STRETCHER | FPO | HILLROM DE MEXICO S DE RL DE CV | 8000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |