MAUDE Adverse Event Report: MEDLINE MEDLINE; WHEELCHAIR

Model Number MDS 809850

Device Problems Break (1069); Physical Property Issue (3008)

Patient Problems Head Injury (1879); Hematoma (1884)

Event Date 03/26/2018

Event Type  Injury  

Event Description

Pt arriving to er for medical treatment for low blood glucose, sat down in wheelchair.Leaned backwards in chair and fabric back of wheelchair ripped apart from the wheelchair base, causing the pt to tumble out of the wheelchair backwards, landing on her head on tile/concrete floor.

• Brand Name: MEDLINE
• Type of Device: WHEELCHAIR
• Manufacturer (Section D): MEDLINE; northfield IL
• MDR Report Key: 7393153
• MDR Text Key: 104271732
• Report Number: 7393153
• Device Sequence Number: 1
• Product Code: KNO
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2018,03/29/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDS 809850
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2018
• Distributor Facility Aware Date: 03/26/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 85