MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE; STANDUP WHEELCHAIR

Model Number Q700-UP M

Device Problem Misassembled During Installation (4049)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 09/20/2021

Event Type  Injury  

Manufacturer Narrative

Background information: risk assessment: pfmea ((b)(4)) lists the following: (1) potential failure mode: "not following safe installation procedures" (2) potential causes of failure: "accidental activation of manual swing away leg rest during installation" (3) potential effects of failure: "assembler injury due to pinch point" gl501f8, rev b., tables of harms and severity lists "broken bones (arm, leg, back (vertebrae), skull, foot, finger, toe) as 3=serious or 4=critical" and "cuts, lacerations, gashes, and tears requiring stitches as 3=serious".Gl501f8, rev b., ufmea definitions, defines 3=serious as "injury or impairment requiring immediate, invasive professional medical intervention." and 4=critical as "permanent impairment".This injury (broken finger) is considered highly unlikely to cause permanent impairment; therefore, a severity of 3=serious is assigned to this particular incident and is potentially likely, should this event recur in the future.A broken finger is considered 3=serious by the complaint assessment team.Double-tilt module replacement instruction sheet (248595, rev.A) provides detailed technical instructions on how to properly replace the double-tilt module on the q700m base (also applies to q700-up m, as they both use the same base).These instructions provide a step-by-step process on the technical instructions for removal of the existing module and installation of the new module.These instructions do not include a note to remove the pin holding the gas strut(s)/cylinder(s).In addition, these instructions do include pictures that show the gas strut(s)/cylinder(s) in the base.Discussion: in reviewing the recorded phone call that was placed during the replacement process the following information (summarized) was gathered: dealer technician and another individual called sunrise medical technical support with questions about component replacement.They said they needed to remove the footrest and actuator from the footrest to put on a new double-tilt module, but that currently the pin was hitting the frame preventing access.Sunrise technical support sent the instruction sheet, 248595 rev.A, to the dealer technician by e-mail and dealer technician acknowledged receipt.It is not clear whether any of the callers then read the instruction sheet.The individuals acknowledged that they did not tilt the frame before removing the chair.Tilting the frame is the first step on the instruction sheet.The callers asked about an alternative solution, connecting direct power to a terminal to move the actuator motor up to access it.A third person joined the call.The callers stated that when power was connected it was tilting, but not raising.One person then said "pull that pin" and told sunrise, "i think we got it, hold on one sec." after the sound of someone hitting something, one person warned another to "keep your fingers out of the way" at approximately minute 35 of the call.You can then hear on the recording phrases such as, "don't let it come crashing down," "i'm going to hold it," "keep your fingers out of it though," and "is there anything spring-loaded on this, because i see there is a gas cylinder on this." at minute 36 of the call, the dealer technician's finger was caught between the footrest and the wheelchair frame resulting in the injury.When asked what happened, a caller said that after taking a pin out the gas cylinder spring let loose and the dealer technician caught his hand between the frame and the footrest assembly.The caller was surprised that there were three gas cylinders and said that they had no idea that it was under pressure.In an email received on september 29, 2021 from numotion vp of safety confirmed that dealer technician was taken immediately to the emergency department where it was determined he suffered a fractured finger and required stitches.The pin that was removed that caused the gas cylinder to release and catch the dealer technician's hand was not the correct pin to be removed for the double-tilt actuator removal or installation.Conclusion: from the context of the phone call, it seems that the dealer technician was not familiar with or did not read the assembly instructions.The dealer technician disassembled the components incorrectly by not following the assembly instructions, resulting in the injury (despite being warned verbally by a colleague).The product functioned as intended and the technical disassembly/reassembly process was not properly followed.There was no product malfunction.Due to the nature and severity of the injury, although there was no product malfunction, this adverse event is being reported.Additional information: this mdr is being filed one day late as the filer's computer was nonfunctional and had to be repaired by the manufacturer's it department before the filing could take place.

Event Description

Dealer technician was replacing double-tilt module on the subject wheelchair when he released a wrong pin and his finger got caught between the footrest and the frame of the wheelchair.He was transported to the hospital where he was diagnosed with a fractured finger and sutures were placed to close the cut on his finger.Information on which finger was involved was not provided; nor the type of fracture.

• Brand Name: QUICKIE
• Type of Device: STANDUP WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• MDR Report Key: 12675331
• MDR Text Key: 282347558
• Report Number: 2937137-2021-00047
• Device Sequence Number: 1
• Product Code: IPL
• UDI-Device Identifier: 00016958059794
• UDI-Public: (01)00016958059794
• Combination Product (y/n): N
• PMA/PMN Number: K172384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: Q700-UP M
• Device Catalogue Number: EIPW25
• Date Manufacturer Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention