FDA Adverse Event Malfunction Summary report: N

STANDARD STRETCHER

MDR report key: 4121855 · Received July 31, 2014

Report

Report Number
3006697241-2014-00594
Event Type
Malfunction
Date Received
July 31, 2014
Date of Event
July 7, 2014
Report Date
July 7, 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 HILL-ROM TECHNICIAN FOUND THREE BRAKE CASTERS AND ONE STEER CATER NOT HOLDING DUE TO NORMAL WEAR AND TEAR. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2011-2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THREE BRAKE CASTERS AND ONE STEER CASTER 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. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
449203 STANDARD STRETCHER WHEELED STRETCHER FPO HILLROM DE MEXICO S DE RL DE CV 8005

Patients

Seq Age Sex Outcome Treatment
1