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

Model Number BLS18FBD-SF

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 10/28/2019

Event Type  Injury  

Event 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
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD; #297 chuqiao road; zhenjiang city; jiangsu, 21200 0; CH 212000
• MDR Report Key: 9443621
• MDR Text Key: 176297879
• Report Number: 2438477-2019-00080
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00822383241159
• UDI-Public: 822383241159
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2019,12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 12/10/2019
• Distributor Facility Aware Date: 10/28/2019
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 54