EVOLUTION 33060400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-02 for EVOLUTION 33060400 manufactured by Sizewise Rentals Llc.

Event Text Entries

[104689331] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7404709
MDR Report Key7404709
Date Received2018-04-02
Date of Report2018-03-29
Date of Event2018-03-21
Date Facility Aware2018-03-21
Report Date2018-03-29
Date Reported to FDA2018-03-29
Date Reported to Mfgr2018-03-29
Date Added to Maude2018-04-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEVOLUTION
Generic NameAIR-FLUIDIZED BED
Product CodeINX
Date Received2018-04-02
Returned To Mfg2018-03-29
Model Number33060400
Device AvailabilityR
Device AgeNA
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerSIZEWISE RENTALS LLC
Manufacturer AddressLENEXA MO 66215 US 66215


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-04-02

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