MAUDE Adverse Event Report: INVACARE IVC SERIES HOMECARE BED

Model Number 1115292

Device Problem Unintended Head Motion (1284)

Patient Problems Laceration(s) (1946); Physical Entrapment (2327); Injury (2348); Choking (2464)

Event Date 11/29/2017

Event Type  Injury  

Event Description

This incident involved an ivc bed manufactured by invacare.On the above date, i raised the bed's head rest, so that i could reach down behind it to retrieve an item i had dropped.As i was reaching, there was a sudden "snap" and the head section of the bed crashed down, so that my left arm became trapped between the head section and the bed frame.As the head section collapsed, my weight was pulled down onto the head section and my neck was trapped against the far side of the headboard.I was literally being choked as my weight was pulling in a manner that my neck was being crushed against the head of the bed while i struggled to free my arm.I was unable to reach the floor with my feet due to my arm being trapped, and the bed was completely locked.I kept trying to use my right hand/arm to gain some leverage but there was no way for me to raise the head section even an inch to help free my trapped arm.I was close to losing consciousness which would've meant death by strangulation when i finally managed to wrench my left arm free.I have attached photos of the damage done to my arms and side.I was seen at the er where doctors determined i'd not broken any bones but suffered extensive damage to soft tissue and ligaments.Also, in a separate incident, i needed to make a trip to the er over the summer (2017) after suffering severe lacerations to my penis caused by sharp edges on the bed frame.These are right in the center of the frame, where the sections are attached in a way to permit the head and foot sections to raise and lower.The design leaves two gaps with exposed metal on each side.I suffered the injury getting into bed.Not certain if the above info pertains to the bed itself or to a bed part (eg linear actuator).Was someone operating the medical device when the problem occurred: yes.If yes, who was using it: the person who had the problem.

• Brand Name: IVC SERIES HOMECARE BED
• Type of Device: IVC SERIES HOMECARE BED
• Manufacturer (Section D): INVACARE
• MDR Report Key: 7237969
• MDR Text Key: 99072254
• Report Number: MW5075033
• Device Sequence Number: 1
• 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: Patient
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1115292
• Other Device ID Number: ITEM # 270007-04
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 44 YR
• Patient Weight: 141