MAUDE Adverse Event Report: BURKE, INC. SIZEWISE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

While in the radiology hallway, six transporters were attempting to move the patient (680 lbs) back to the ambulatory surgery unit (asu) nursing unit.The power system on the bed failed and the transporters were unable to disengage the drive wheel to gain neutral mobility.The wheels were locked in the forward position.The six transporters struggled to move the dead bed into the elevator wherein it only cleared after an exorbitant amount of effort to push and squeeze the rails inward.Movement of the bed resulted in the front wheels becoming outwardly bent.No injury to patient or staff but was felt to be a potential harm and/or injury to employees.

• Brand Name: SIZEWISE
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): BURKE, INC.; 1800 merriam ln.; kansas city KS 66106
• MDR Report Key: 4663506
• MDR Text Key: 18658836
• Report Number: 4663506
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/12/2015
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2015
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR