MAUDE Adverse Event Report: FORT METAL PLASTIC CO., LTD DRIVE MEDICAL; AID, TRANSFER

Model Number RTL15073

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

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

Event Date 02/23/2015

Event Type  Death  

Event Description

(b)(4) received notice regarding the incident from health (b)(6), involving a home bed assist handle, a product imported and distributed by (b)(4).The end user was found deceased, with his face pointing away from the bed.His neck was allegedly compressed between the bed assist handle and the mattress.The lower part of his body was on the floor.Emergency medical services was called but they were unable to resuscitate him.As per coroner's report, cause of death was allegedly determined to be neck compression due to/as a consequence of bed rail entrapment, with a contributing factor of atherosclerotic and hypertensive heart disease.(b)(4) has no information on the quality of home bed and mattress and their configuration including the drive assist handle.There is also no report regarding whether an entrapment risk assessment has been performed on this particular home care bed setting.This report is based on the information that was provided by health (b)(6).

• Brand Name: DRIVE MEDICAL
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): FORT METAL PLASTIC CO., LTD; yi he civil affairs ind area; guongdong guangdong, 51602 3; CH 516023
• MDR Report Key: 6075415
• MDR Text Key: 59035277
• Report Number: 2438477-2016-00055
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2016,10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL15073
• 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: 11/03/2016
• Distributor Facility Aware Date: 10/07/2016
• Event Location: Other
• Date Report to Manufacturer: 11/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 92 YR
• Patient Weight: 88