MAUDE Adverse Event Report: APEX MEDICAL (KUNSHAN) CORP. ENDURANCE DELUXE ALTERNATING PRESSURE PUMP AND PAD; APP

Model Number	9C526002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Asphyxia (1851); Physical Entrapment (2327)
Date of Event	02/06/2017
Type of Reportable Event	Death
Event or Problem Description
Patient's spouse found him hanging over the side of bed, head first, and wedged between hospital bed and wall of home.Police pronounced him dead at scene.Hospice service filed medwatch report on all equipment present at the scene.Review of scene photographs show an app matress securely placed under a contour sheet; the sheet and pad remained properly in place on bed.The app system appears non-contributory in patient's death.

• Brand Name: ENDURANCE DELUXE ALTERNATING PRESSURE PUMP AND PAD
• Common Device Name: APP
• Manufacturer (Section D): APEX MEDICAL (KUNSHAN) CORP.; no. 1368, zi zhu road; kunshan city, jiangsu 21530 0; CH 215300
• MDR Report Key: 6336139
• Report Number: 1056127-2017-00003
• Device Sequence Number: 1105485
• Product Code: FNM
• UDI-Device Identifier: 00754756390013
• UDI-Public: 754756390013
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2017
• Report Date (Section F): 02/16/2017

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: Medical Equipment Company Technician/Representative
• Device Model Number: 9C526002
• Device Catalogue Number: D9000C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 02/16/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HOSPITAL BED AND BED RAILS
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Weight: 56
• Date Report Sent to FDA: 02/16/2017