MAUDE Adverse Event Report: SIZEWISE RENTALS LLC EVOLUTION; AIR-FLUIDIZED BED

Model Number 33060400

Device Problems Mechanical Problem (1384); Human-Device Interface Problem (2949); Unintended Movement (3026)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)

Event Date 03/21/2018

Event Type  Injury  

Event Description

While lift team was transitioning paraplegic pt from one sizewise bed to another using a draw sheet method, first bed shifted sideways and pt fell between the beds.Lift team caught pt at her head/shoulders, but there was pt impact with the floor.Lift team states they set brakes on both beds prior to the transfer.Device was sequestered and inspected by both a hospital bmet, a hospital biomedical engineer, and a mfr service engineer.Brakes were tested, and they were found to operate as designed.No device failure found.However, the front and rear brake systems do not operate the same, so that users must push the head-end (red) brake pedal down as well as pulling the foot-end (green) brake pedal up in order for all casters to lock, regardless of caster direction.Therefore, pushing down on the foot-end brake pedal does not lock the foot-end casters until they are fixed in the forward direction (presumably for steering purposes).We believe it is very possible that the lift team pushed down on both head and foot-end brake pedals, assuming this locked all four casters, but which may have allowed the foot-end casters to move sideways during pt transfer if the casters weren't in the front fixed position.We believe that this incident was a result of poor device design and/or lack of proper brake use labeling.It is to be noted that, although this incident occurred with a sizewise evolution bed, this counter-intuitive brake design is not exclusive to this model, as we saw other sizewise models in-house with the same design.

• Brand Name: EVOLUTION
• Type of Device: AIR-FLUIDIZED BED
• Manufacturer (Section D): SIZEWISE RENTALS LLC; lenexa MO 66215
• MDR Report Key: 7404709
• MDR Text Key: 104689331
• Report Number: 7404709
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 33060400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2018
• Distributor Facility Aware Date: 03/21/2018
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR