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

Model Number 9C526002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Asphyxia (1851); Physical Entrapment (2327)

Event Date 02/06/2017

Event Type  Death  

Event 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
• Type of Device: APP
• Manufacturer (Section D): APEX MEDICAL (KUNSHAN) CORP.; no. 1368, zi zhu road; kunshan city, jiangsu 21530 0; CH 215300
• MDR Report Key: 6336139
• MDR Text Key: 67595657
• Report Number: 1056127-2017-00003
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00754756390013
• UDI-Public: 754756390013
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2017,02/14/2017

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
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: 9C526002
• Device Catalogue Number: D9000C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2017
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 02/16/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HOSPITAL BED AND BED RAILS
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 56