MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q700-UP M / Q700M

Model Number	Q700-UP M / Q700M
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end user reported an alleged burn incident while using the chair's ctrl+5/ca-5 module to charge a personal heart monitor device, which is not an accessory or device associated with sunrise medical.Review of the available photographs and field inspection identified no visible burn marks, melting, or external signs of overheating on the module or the end user's hand.The charging cable involved in the event was not available for evaluation.Although no device malfunction or definitive fault of the sunrise medical device has been confirmed during the initial investigation, an mdr was submitted out of an abundance of caution due to the allegation of a serious injury requiring medical treatment and the reported occurrence of heat and smoke during use.The report was filed to comply with applicable vigilance and mdr reporting requirements while the investigation remains ongoing.
Event or Problem Description
The end user reported that while operating the power wheelchair and utilizing the ctrl+5/ca-5 module to charge a personal heart monitor device, smoke and heat were observed from the charging area and connected cable.The user alleged a burn injury to the right palm requiring hospital treatment.The dealer reported that the charging accessory had reportedly been used routinely since delivery of the chair.A replacement ca-5 module was previously installed under warranty.A field review and visual inspection of the returned component were performed by the sales representative/dealer.No visible melting, deformation, or external signs of overheating were observed on the ca-5 module.The specific charging cable and connected accessory involved in the event were not available for evaluation.Photographs of the component were obtained and attached to the complaint file.Investigation remains ongoing to assess the relationship between the reported event, accessory usage, and device performance.

• Brand Name: QUICKIE Q700-UP M / Q700M
• Common Device Name: QUICKIE Q700-UP M / Q700M
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 12002 volunteer blvd; mt. juliet TN 37122
• Manufacturer Contact: neeraj patel ; 12002 volunteer blvd; mt. juliet, tn, TN 37122 ; 8003334000
• MDR Report Key: 25094257
• Report Number: 3019677893-2026-00009
• Device Sequence Number: 20103439
• Product Code: ITI
• UDI-Device Identifier: 00016958059793
• UDI-Public: 00016958059793
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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 Model Number: Q700-UP M / Q700M
• Device Catalogue Number: EIPW25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female