MAUDE Adverse Event Report: STAXI CORPORATION LTD. STAXI TRANSPORT CHAIR; WHEELCHAIR, MECHANICAL

Model Number ST010-R

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Fall (1848); Head Injury (1879); Hemorrhage, Cerebral (1889)

Event Date 08/16/2017

Event Type  Death  

Event Description

The patient was placed on a transportation staxi wheelchair and had an unwitnessed fall on the floor in the emergency room and hit his head, which resulted in a intraparenchymal hemorrhage with midline shift.

• Brand Name: STAXI TRANSPORT CHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): STAXI CORPORATION LTD.; richard hettenbach; 44 countrywood dr; morris plains NJ 07950
• MDR Report Key: 7078472
• MDR Text Key: 93584118
• Report Number: 7078472
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2017,11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: ST010-R
• Device Catalogue Number: ST010-R
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Death
• Patient Weight: 54