MAUDE Adverse Event Report: INVACARE FLORIDA IVC BARIATRIC BED 9153641598; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number NA:BAR600IVC

Device Problems Break (1069); Collapse (1099)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2023

Event Type  malfunction  

Manufacturer Narrative

This incident is being reported in an abundance of caution.The end user initially was working with the dealer but has since stopped responding to calls.The dealer had a scheduled appointment to inspect the device, but the end user has not responded.The user continues to use the device against recommendations from the provider and invacare.It is unclear what, if any, malfunction occurred.It is unclear if the end user attempted to modify, repair, or adjust the mechanics of the bed.It is unclear how or why the bed fell.It is unclear how, or what bolt became loose, or even if the bolt was the original bolt, or had been replaced.Without return of the bed or more information no conclusions can be made.A request has been made for a return of the bed, but the end user has stopped cooperating with the dealer.If additional information becomes available and changes the current findings a supplemental record will be filed.This device was over 1 year old at the time of this incident.The serial number provided was for the bed ends; therefore, the bed model number was used to determine the proper manufacturing location which was invacare sanford.

Event Description

It was reported the bed fell to the lowest setting, the motor shaft became disconnected, and a bolt was missing from the bed and was found imbedded in a wall.

• Brand Name: IVC BARIATRIC BED 9153641598
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• 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 44035 ; 8003336900
• MDR Report Key: 17651452
• MDR Text Key: 322296874
• Report Number: 1031452-2023-00018
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:BAR600IVC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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 Sex: Female
• Patient Weight: 147 KG