MAUDE Adverse Event Report: INVACARE FLORIDA IVC FULL ELECTRIC LOW BED 9153642101; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number NA:5410LOW

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Swelling (2091)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

The bed was not returned to invacare, due to the end user had it disposed of.The end user stated the last time she was weighed she was (b)(6) and the maximum patient weight for this bed is 350 lb.The end user has preexisting lymphedema in her legs and they must stay elevated.Because of the bed breaking in the middle she could not keep her legs elevated she developed cellulitis and had to be on antibiotics.The end user received a prescription for a new bed from her dr.And received a new bed.Should additional information become available, a supplemental record will be filed.

Event Description

The end user called and stated that she had a 5410 low bed that broke in the middle, in which she slid down and was stuck.She eventually slid off of the bed and onto the floor, where she remained for several hours until a family member came and called the fire department to help her up.She stated that the incident did not cause any injuries, but the fire department put a sheet behind her and under her arms to help her up, and she felt like that may have bruised her arms.

• Brand Name: IVC FULL ELECTRIC LOW BED 9153642101
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 8629065
• MDR Text Key: 145680736
• Report Number: 1031452-2019-00012
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:5410LOW
• Device Catalogue Number: 5410LOW
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 175