MAUDE Adverse Event Report: INVACARE CORP. INVACARE HILO BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number J5858941, J6172555, R676295

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

Patient Problems Fall (1848); Physical Entrapment (2327)

Event Date 11/16/2017

Event Type  Injury  

Event Description

Patient was found fallen out of his bed with his arm trapped in the side rail by his wife.His son was able to get his arm out of the rail and contacted the non emergency fire department to get him back into the bed.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE HILO BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE CORP.
• MDR Report Key: 17536255
• MDR Text Key: 321101463
• Report Number: MW5143145
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: J5858941, J6172555, R676295
• Patient Sequence Number: 1
• Patient Age: 93 YR