FDA Adverse Event Malfunction Summary report: N

V RISER

MDR report key: 2308108 · Received October 18, 2011

Report

Report Number
2308108
Event Type
Malfunction
Date Received
October 18, 2011
Date of Event
September 26, 2011
Report Date
October 18, 2011
Manufacturer
NOA MEDICAL INDUSTRIES, INC.
Product Code
FNL
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IA, US

Narratives

Description of Event or Problem · 1

PATIENT WHO WAS ADMITTED WITH CROHN'S DISEASE AND FISTULOUS TRACT TO SACRUM AND STAGE IV SACRAL ULCER HAD SURGICAL AND INFECTIOUS DISEASE SURGICAL WORK-UP PRIOR TO SURGICAL DEBRIDEMENT AND DEEP SACRAL BONE BIOPSY FLAP CLOSURE. ON THE DAY OF THE EVENT, THE PATIENT WAS LYING IN A RECOVERCARE LOW BED THAT BEGAN RISING UP AND LOWERING, THEN MOVED INTO A TRENDELENBURG POSITION BY ITSELF. THE PATIENT WAS FOUND AT 80 DEGREE ANGLE AND WAS MOVED TO A REGULAR BED WITH MATS. PATIENT WAS NOT HARMED BY THE EVENT. PATIENT WAS DISCHARGED HOME POST OP DAY 11 TO HOME CARE FOLLOW-UP.THE RECOVERCARE BED WAS RETURNED TO THE RENTAL COMPANY, WHO INSPECTED IT AND FOUND NO ELECTRICAL PROBLEMS, WIRING PROBLEMS, OR SHORTS, NO ELECTRICAL CURRENT LEAKS. THIS MODEL OF BED HAS 2 HAND CONTROLLERS, ONE AT THE FOOT OF THE BED AND ONE AT THE HEAD OF THE BED. RECOVERCARE TECHNICIANS WERE ABLE TO RECREATE A SIMILAR SITUATION WITH THE HAND CONTROLLER BETWEEN THE FOOT OF THE MATTRESS AND THE FOOTBOARD, THEN APPLYING PRESSURE ON THE MATTRESS, RESULTING IN THE BED OPERATING AND MOVING THE BED UP AND THEN INTO TRENDELENBURG POSITION. A SIMILAR EVENT OCCURRED APPROXIMATELY TWO WEEKS PRIOR AT THIS HOSPITAL AND WAS REPORTED. THE HOSPITAL SENT A SAFETY ALERT TO NURSING LEADERSHIP FOLLOWING THESE 2 EPISODES, ADVISING STAFF THAT IF THIS MODEL IS USED, THE LOWER HANDSET SHOULD BE SECURED. ALTHOUGH THE CONTROLLER MAY BE INITIALLY "SECURED", IF VISITORS OR FAMILY MEMBERS USE IT TO OPERATE THE BED, IT MAY NOT END UP BACK IN THE "SECURED" POSITION. THE HOSPITAL REQUESTED THAT THE RENTAL COMPANY DELIVER ONLY BEDS THAT HAVE 1 SET OF HAND CONTROLLERS FOR THE HEAD OF THE BED.======================MANUFACTURER RESPONSE FOR LOW BED, RECOVERCARE ULTRA HI LO BED V RISER (PER SITE REPORTER).======================RESPONSE FROM DISTRIBUTOR IS INCLUDED IN THE EVENT SECTION. DISTRIBUTOR IS WORKING WITH MANUFACTURER ON THIS COMPLAINT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 V RISER BED, ADJUSTABLE HOSPITAL FNL NOA MEDICAL INDUSTRIES, INC. RCUHLB *

Patients

Seq Age Sex Outcome Treatment
1 69 YR NO OTHER THERAPIES