MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE; WHEELCHAIR

Model Number	BLS18FBD-SF
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a wheelchair.The device was repaired.The broken upholstery was discarded.No evaluation can be make on the part.The end-user is a double amputee.The backrest of the wheelchair ripped on both sides and he ended up falling out of the chair.He may have hit his head.He was brought to the hospital and the doctors said he had a stroke.It is unclear whether he had a stroke and fell or if the event caused the stroke.The patient was in the hospital for about 3 weeks and now is in a rehab facility.A replacement back was supplied by our customer service department and it was utilized on the device.The ripped back upholstery was discarded.At this time no pictures are available.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; #297 chuqiao road; zhenjiang city; jiangsu, 21200 0; CH 212000
• MDR Report Key: 9443621
• Report Number: 2438477-2019-00080
• Device Sequence Number: 2877373
• Product Code: IOR
• UDI-Device Identifier: 00822383241159
• UDI-Public: 822383241159
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/09/2019
• Report Date (Section F): 12/10/2019

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: BLS18FBD-SF
• Device Catalogue Number: BLS18FBD-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/28/2019
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 58 YR
• Patient Weight: 54
• Date Report Sent to FDA: 12/10/2019