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