FDA Adverse Event Malfunction Summary report: N

TOTALCARE BARIATRIC BED

MDR report key: 4003121 · Received June 26, 2014

Report

Report Number: 1824206-2014-01854
Event Type: Malfunction
Date Received: June 26, 2014
Date of Event: June 1, 2014
Report Date: June 1, 2014
Manufacturer: HILL-ROM, INC.
Product Code: IOQ
PMA / PMN Number: K122473
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE HILL-ROM TECHNICIAN COULD NOT REPAIR THE BRAKES ONSITE. THE BED WAS SWAPPED WITH A KNOWN WORKING BED. AT A HILL-ROM SERVICE CENTER THE FOOT END BRAKE CASTER WERE FOUND NOT HOLDING. PER THE HILL-ROM SERVICE MANUAL THE TOTALCARE BED SYSTEM REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM A SEMI-ANNUAL PREVENTATIVE MAINTENANCE. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. TEST THE BRAKE CASTERS TO DETERMINE IF THE BED MOVES WHEN YOU ACTIVATE THE BRAKE, REPLACE OR ADJUST WHEN NECESSARY. CHECK THE TIRES FOR CUTS, WEAR, TREAD LIFE, ETC. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE FOOT END CASTERS 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 ARE NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT ON THE 4TH FLOOR. THERE WAS NO PATIENT/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
373176	TOTALCARE BARIATRIC BED	A/C POWERED ADJUSTABLE HOSPITAL BED	IOQ	HILL-ROM, INC.	1840

Patients

Seq	Age	Sex	Outcome	Treatment
1