MAUDE Adverse Event Report: CARROLL HEALTHCARE / INVACARE CORP. CARROLL ASSIST RAIL; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number ELH0880

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

Patient Problems Death (1802); Asphyxia (1851)

Event Date 09/18/2019

Event Type  Death  

Event Description

Resident died due to accidental positional asphyxiation.Fda safety report id# (b)(4).

• Brand Name: CARROLL ASSIST RAIL
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE / INVACARE CORP.
• MDR Report Key: 9116191
• MDR Text Key: 160160245
• Report Number: MW5089991
• Device Sequence Number: 2
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/20/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ELH0880
• Is the Reporter a Health Professional?: Yes
• 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): Death
• Patient Age: 94 YR
• Patient Weight: 91