MAUDE Adverse Event Report: INVAMEX ECON W/C PERMANENT PAD ARM; WHEELCHAIR, MECHANICAL

Model Number TRP8SA080

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

The hospital quality and risk manager stated that the wheelchair is owned by the hospital and is kept folded up in a closed position by the front entrance for family members to use when they need to transport a patient into or out of the hospital.No medical personnel supervise the use of this chair.The tracer wheelchair user manuals state, "always keep hands and fingers clear of moving parts to avoid injury.Do not place hand or fingers on the underside of the seat frame rail when opening or closing the wheelchair.Do not sit or transfer into the wheelchair unless it is fully open and the seat frame rails are fully seated into the side frame h-blocks." the hospital quality and risk manager was aware that the chair should be fully opened before a patient sits in the chair; however, not all chair users would be mindful of these warnings, since the chair is being used in a public place by individuals who have not read the manual.Because of this, invacare recommends that a non-folding device be installed to keep the wheelchair from being folded when left unoccupied in a public place.The hospital quality and risk manager stated that they have considered getting non-folding devices for the chairs being used at the hospital entrance; however, they have limited space, so they may instead put up a sign that instructs the users to open the chair fully before use.Although there was no alleged product malfunction, the wheelchair was returned to invacare for an evaluation, which is in-process.A replacement wheelchair was sent to the hospital, and it was suggested that they put up a sign immediately to prevent any further injuries with the other chairs in their fleet.

Event Description

The quality and risk manager at an outpatient hospital reported that approximately 6-8 months ago, a patient's left index finger was pinched while they were attempting to sit down in the tracer wheelchair.She indicated that the patient put their hands on the seat rails of the chair and sat down before the chair was completely opened, using their weight to open up the chair the rest of the way.She stated that the tip of their finger was cut, so they were taken immediately into surgery.They tried to reattach the tip of the finger, but they were unsuccessful, so it was amputated.The patient had to have a second surgery when their nail began to regrow on the part of the finger that was remaining.

Manufacturer Narrative

An evaluation of the wheelchair was completed on (b)(6) 2018.It was confirmed that it is possible for an individual to pinch their fingers between the seat rail and side frame if the chair is not fully expanded before sitting down.However, the chair functioned as designed.There were no sharp edges on either seat rails or side frames.It was verified that there was no product malfunction associated with the injury.The adverse event appears to have been an accident that resulted from user error; the patient sat down before the chair was fully opened.

• Brand Name: ECON W/C PERMANENT PAD ARM
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 7233507
• MDR Text Key: 98739483
• Report Number: 9616091-2018-00002
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TRP8SA080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/1998
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Disability