MAUDE Adverse Event Report: PROBASICS; TRANSPORT CHAIR

Model Number 9201

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Brain Injury (2219)

Event Date 01/14/2016

Event Type  Injury  

Event Description

On 02/25/2019 we were notified of a court motion with no further information.On 05/23/2019 pictures of the device (transport chair) were received.On 08/22/2019 legal documents were provided with information of incident that were not seen until 10/10/2019: the end-user fell from a wheelchair onto her face onto the floor of a transport van.She had bleeding from her nose and face.Received ct scan of head 10/23/13 showed moderate cerebral atrophy and with remote left temporoparietal craniotomy and underlying encephalomalacia (had previous gun shot to head).The ct from 1/14/16 showed fractures of the sinus walls, orbital fractures, and front scalp hematoma.Also noted were fractures of the posterior ring of the c5 and c6.One doctor states she received a traumatic brain injury and one states she did not.The incident is described as "the claimant's seatbelt snapped and she came out of the wheelchair and face planted onto the floor of the transport van." she was admitted in the hospital from (b)(6) 2016 to (b)(6) 2016.She had bleeding of nose and mouth.Doctors stated no surgical procedure and a cervical collar was applied.She was previously shot in the head and had a hip replacement, had decreased mental capacity, slurs words, and right side weakness due to gunshot.Serial number provided is from 2003, years before chb had the acquisition with probasics.No historical information is available.

• Brand Name: PROBASICS
• Type of Device: TRANSPORT CHAIR
• MDR Report Key: 9179388
• MDR Text Key: 161990625
• Report Number: 3012316249-2019-00034
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2019
• Distributor Facility Aware Date: 08/22/2019
• Event Location: Other
• 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: 76 YR