FDA Adverse Event Malfunction Summary report: N

STANDARD STRETCHER

MDR report key: 3823287 · Received February 27, 2014

Report

Report Number: 3006697241-2014-00190
Event Type: Malfunction
Date Received: February 27, 2014
Date of Event: January 30, 2014
Report Date: January 30, 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 LOCKING MECHANISMS WERE WORN OUT ON ALL FOUR BRAKE CASTERS. PER THE HILL-ROM SERVICE MANUAL THE BED SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. AN ANNUAL SERVICE OF THE BED IS ADVISED IN ORDER TO MAINTAIN ITS CHARACTERISTICS AND PERFORMANCE. BRAKE CASTERS SHOULD BE CHECKED FOR CUTS, WEAR AND QUALITY OF TREAD, ETC. AND REPLACED WHEN NECESSARY. APPLY THE BRAKE AND MAKE SURE THE STRETCHER DOES NOT MOVE. IF THERE IS MOVEMENT, LOOK AT THE BRAKE COMPONENTS FOR WEAR. APPLY THE STEER, AND MAKE SURE THE STRETCHER STEERS CORRECTLY. LOOK AT THE STEER COMPONENTS FOR WEAR. PUT THE STRETCHER IN NEUTRAL. MAKE SURE ALL FOUR CASTERS ROTATE AND ROLL FREELY. ADJUST OR REPLACE COMPONENTS IF NECESSARY. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2009-2014. 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 THE ACCOUNT STATING THE BRAKES WERE NOT HOLDING. THE BED WAS LOCATED IN THE BASEMENT. 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
122606	STANDARD STRETCHER	WHEELED STRETCHER	FPO	HILLROM DE MEXICO S DE RL DE CV	8005

Patients

Seq	Age	Sex	Outcome	Treatment
1