MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC EMPULSE; WHEELCHAIR ACCESSORIES

Model Number R20 POWER ASSIST

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 09/06/2023

Event Type  Injury  

Event Description

Dealer reports that while using the r20 power assist for the first time, the end user wrecked her wheelchair.The end user went to the emergency room.She was evaluated for a concussion and received stiches.There is limited information provided on the incident and the reported injuries sustained by the end user.

Manufacturer Narrative

Background: empulse r20 owner's manual, page 7 states: "before assisting a wheelchair user, read all warnings contained in this manual, and follow all instructions that apply.Be aware that after consulting a health care provider, it is necessary to learn safe and proven body mechanics to use and create assistive methods best suited to one's abilities." empulse r20 owner's manual, page 7 states: "1.Before beginning use of the device, one should be trained in the safe use of the device by a health care provider.2.First, with the device attached to the chair, practice propelling the wheelchair at slow speeds and in open areas.3.It is necessary to develop methods for safe use best suited to one's level of function and ability.4.Never try a new maneuver alone.Ask the advice of a health care provider to lower the risk of a fall or tip-over." discussion: in reviewing the complaint, the dealer reported that while using the r20 power assist for the first time, the end user wrecked her wheelchair.There is limited information provided on the incident and the reported injuries sustained by the end user.There is no indication that the wheelchair malfunctioned.After the alleged incident, the end user went to the emergency room.She was evaluated for a concussion and received stiches.No additional details regarding injury or treatment were provided.The dealer reports that the end user is fine now.Conclusion: in conclusion, there were no claims of malfunction or defect made against the wheelchair.Based on the limited reported injuries and the allegation of a serious injury (stitches), this mdr is being filed.

• Brand Name: EMPULSE
• Type of Device: WHEELCHAIR ACCESSORIES
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727 ; 5592942374
• MDR Report Key: 17882143
• MDR Text Key: 325044241
• Report Number: 2937137-2023-00015
• Device Sequence Number: 1
• Product Code: KNO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2023

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: R20 POWER ASSIST
• Device Catalogue Number: EISP9
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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 Sex: Female