MAUDE Adverse Event Report: SIZEWISE SIZEWISE; BARIATRIC EVOLUTION

Model Number 99330610

Device Problems Break (1069); Entrapment of Device (1212); Arcing (2583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2017

Event Type  Injury  

Event Description

Re: sizewise evolution patient bed frame/ auxiliary outlet with mount powermate (27001669).The model number for the evolution bed frame is part #33060400.The bariatric evolution bed from part # is 99330610.The outer insulation of the auxiliary outlet power cord on an inpatient bed was compromised, exposing the internal wire, causing arcing to occur.The original factory installed power cord strain relief device proved inadequate and failed.The failure allowed the power cord to be caught in the lift mechanism.Black soot was found on the bedframe after the reporting of arcing.No patient or staff were harmed.Follow up action: inspection of all beds in the hospital were conducted to identify unsecured auxilliary power cords.The hospital was authorized by the manufacturer to install a temporary form of restraint for the power cord.A permanent fix was designed by the manufacturer, implemented and installed on all of the beds.

• Brand Name: SIZEWISE
• Type of Device: BARIATRIC EVOLUTION
• Manufacturer (Section D): SIZEWISE; lenaxa KS
• MDR Report Key: 7221624
• MDR Text Key: 98462792
• Report Number: MW5074897
• Device Sequence Number: 3
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99330610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention