FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR STRETCHER
MDR report key: 3850807
·
Received March 21, 2014
Report
- Report Number
- 3006697241-2014-00261
- Event Type
- Malfunction
- Date Received
- March 21, 2014
- Date of Event
- February 21, 2014
- Report Date
- February 21, 2014
- Manufacturer
- HILLROM DE MEXICO S DE RL DE CV
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THAT WHEN BRAKE/STEER PEDAL IS SET TO BRAKE MODE, THE HEAD END BRAKE CASTERS DO NOT ENGAGE/HOLD. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FORM THE ACCOUNT STATING THE HEAD END CASTER WILL NOT LOCK (BRAKES NOT HOLDING). THE BED WAS LOCATED AT THE ACCOUNT IN THE BED SHOP. 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 |
|---|---|---|---|---|---|---|---|
| 170469 | TRANSTAR STRETCHER | WHEELED STRETCHER | FPO | HILLROM DE MEXICO S DE RL DE CV | 8020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |