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	Malfunction
Additional Manufacturer Narrative
Drive medwatch report #2438477-2023-00002.Incident device: ssp216dda-sf serial number #: (b)(6).The investigation of incident is described as below: how many similar mdr, complaints, or service requests for the same product have you received over the past three (3) years? we have not received any similar mdr, complaints or service request for the same product over the past three years.If you have received reports of the similar problem, for each case, what was the root cause and corrective actions? n/a. is there a change on the design of the item since then that will require a new static load test and fatigue test.There is no changes on the design of the item.The static load test and fatigue test reports are shown in the attachment.Please provide a copy of the final quality inspection record on this particular piece of device? please find the inspection record as attached.Lastly, what is the manufacture date of this particular piece of device? (b)(6) 2021.
Event or Problem Description
On (b)(6) 2023, we received a email from our customer drive devilbiss healthcare about this adverse event.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).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 (Section G): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD; no.36, danyan road,; danyang, jiangsu 21230 0; CH 212300
• Manufacturer Contact: bellinda deng ; no.36, danyan road; danyang, jiangsu 21230-0 ; CH 212300
• MDR Report Key: 17015399
• Report Number: 3014810929-2023-00001
• Device Sequence Number: 12348256
• Product Code: IOR
• UDI-Device Identifier: 00822383145280
• UDI-Public: 822383145280
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K200466D4461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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
• Device Catalogue Number: SLVESPRT2,16IN SLVRVEINDETDSK
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 05/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2021
• 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