MAUDE Adverse Event Report: SUNRISE MEDICAL QUICKIE; WHEELCHAIR, MECHANICAL

Model Number QUICKIE GPSA WHEELCHAIR

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

Patient Problem Pain (1994)

Event Date 05/25/2023

Event Type  Injury  

Event Description

The end user reports an incident that occurred in (b)(6) 2023 where he fell backwards from his wheelchair while transferring from his bed.The end user alleged that he fell on his neck and head.He stated there was an 8-10 inch gap between the wheelchair and the mattress.On december 5, 2023, the end user sent an email describing "horrific" pain (including nerve pain) that stemmed from the fall that occurred in (b)(6) 2023.There is no evidence of malfunction or defect from the wheelchair.

Manufacturer Narrative

Background information: the quickie gp series owner's manual (100309 rev b) page 5 states: "unauthorized modifications and use of parts or accessories not supplied or approved by sunrise medical may change the chair structure.This will void the warranty and may cause a safety hazard.If the warning is ignored, damage to your chair, and the potential severe injury of the person using the chair for unintended purposes can occur." the quickie gp series owner's manual (100309 rev b) page 10 states: "it is dangerous to transfer on your own.It requires good balance and agility.Be aware that there is a point during every transfer when the wheelchair seat is not below you." discussion: in reviewing the complaint, the end user initially reported on september 28, 2023, that he fell backwards from his wheelchair while transferring from his bed.The end user alleged that he fell on his neck and head.He stated there was an 8-10 inch gap between the wheelchair and the mattress.The end user states that he believed the space between the backrest and the seat is too wide for the wheelchair.According to the end user's previous dealer, the end user had a permobil visco back (not supplied by sunrise medical) installed on the quickie gp wheelchair.There was no further information on whether the atp or the end user requested the specific wheelchair back.On december 5, 2023, the end user sent an email describing "horrific" pain (including nerve pain) that stemmed from the fall that occurred in (b)(6) 2023.The end user also alleged that he has been taking narcotic pain medication since (b)(6) 2023 for the pain he described.Furthermore, in the email, the end user describes the gap that was mentioned when the case was first recorded.He also reported extra pieces of metal on the front of the chair that create imbalance.This was not noted during the first communications in september 2023, and it was not mentioned if this imbalance was present during the (b)(6) 2023 fall.A dhr review for this product was conducted and no ncmr or deviation were identified in the production record that are potentially related to the failure reported.The review was completed and concluded that the product was manufactured under normal conditions.There is no evidence of malfunction or defect from the wheelchair.The sunrise medical legal representative had another conversation with the end user where he described an incident that resulted in a partial fall.The end user stated he fell ¾ out of the wheelchair while transferring.His transfer board went in between the gap in the back of the wheelchair that has been mentioned previously.He stated he hit his left arm.He reported that his left hand allegedly went numb/tingling like if he had been sleeping on it.No medical appointments have been made and the end user stated he has been doing stretching exercises to help.A follow up email was sent by the end user where he alleged sore ribs, pain in the cervical area of the neck and increased pain in the sacrum and coccyx.Conclusion: in conclusion, there is no evidence of malfunction or defect from the wheelchair.This device is used for treatment, not diagnosis.Due to the allegation of a serious injury (severe pain), this mdr is being filed.

• Brand Name: QUICKIE
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): SUNRISE MEDICAL; 2842 n business park ave; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL; 2842 n business park ave; fresno CA 93727
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727
• MDR Report Key: 18383848
• MDR Text Key: 331217313
• Report Number: 2937137-2023-00018
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00016958043891
• UDI-Public: 00016958043891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: QUICKIE GPSA WHEELCHAIR
• Device Catalogue Number: EIGPSA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 91 KG