MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD DRIVE; WHEELCHAIR

Model Number	SSP216DDA-SF
Medical Device Problem Codes	Device Slipped (1584); Use of Device Problem (1670)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Loss of consciousness (2418)
Date of Event	12/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received any similar mdr, complaints or service request for the same product over the past three years.There is no changes on the design of the item.The static load test and fatigue test reports are shown in the attachment.Please find the inspection record as attached.The manufacture date of this particular piece of device is 09/08/2021.
Event or Problem Description
We received the email from our customer drive, the details as below: please find attached a copy of the drive medwatch report # 2438477-2023-00002.The medical device involved in the incident is a slvesprt2,16in slvrveindetdsk,swgft,1/cs, model number ssp216dda-sf.The serial number is (b)(6).Please refer to the medwatch report for information about the event.As of today, the product in question has not been returned to drive medical for evaluation.Drive devilbiss healthcare was notified of an incident involving a wheelchair by an end user, who stated that she was using the wheelchair "on the sidewalk up a ramp," when it was "raining a lot and cold," and where "there were a lot of leaves so it was slippery." she was reportedly "thrown out of the chair" and was rendered unconscious.When she regained consciousness, "the chair was on top of her," and she sustained 3 broken ribs.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD; no.36, danyan road; danyang, jiangsu 21230 0; CH 212300
• Manufacturer Contact: belinda deng ; no.36, danyan road; danyang, jiangsu 21230-0 ; CH 212300
• MDR Report Key: 17993197
• Report Number: 3011677477-2023-00001
• Device Sequence Number: 15340646
• Product Code: IOR
• UDI-Device Identifier: 00822383145280
• UDI-Public: 822383145280
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082784D2428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: SSP216DDA-SF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2023
• Initial Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 72 KG