FDA Adverse Event Malfunction Summary report: N

TOTAL CARE BED

MDR report key: 3823406 · Received February 28, 2014

Report

Report Number: 1824206-2014-00672
Event Type: Malfunction
Date Received: February 28, 2014
Date of Event: January 31, 2014
Report Date: January 31, 2014
Manufacturer: HILL-ROM, INC.
Product Code: FNL
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE TECHNICIAN INVESTIGATED AND PLUGGED IN THE BED AND THE BED MOVED UP ON ITS OWN. THE TECHNICIAN FOUND THE GASKET ON THE SIDE RAIL WAS WORN ALLOWING CLEANING FLUID TO EGRESS AND CORRODE THE CAREGIVER BOARD CAUSING THE BUTTONS TO STICK WHICH CAUSED THE BED TO MORE UNINTENTIONALLY. 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 BED FUNCTION CONTROLS FOR PROPER OPERATION OF THE FUNCTION AND MOMENTARY OPERATION. TEST ALL LOCKOUT CONTROLS AND INDIVIDUALLY CHECK FOR PROPER OPERATION. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2005. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE LEFT SIDE RAIL CAREGIVER BOARD AND THE INTERNAL CABLE ASSEMBLY GASKET TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

THE ACCOUNT REPORTED THE BED FUNCTIONS BY ITSELF. THE BED WAS IN MICU STORAGE AT THE FACILITY. 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
123752	TOTAL CARE BED	A/C POWERED ADJUSTABLE HOSPITAL BED	FNL	HILL-ROM, INC.	1900

Patients

Seq	Age	Sex	Outcome	Treatment
1