MAUDE Adverse Event Report: INVAMEX IVC BARIATRIC BED 9153641598; BED, AC POWERED ADJUSTABLE HOSPITAL

Model Number	NA:BAR600IVC
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is being filed in an abundance of caution.This device was over 12 years old at the time of this issue.However, the junction box was roughly 4 years old.This device was manufactured by invacare sanford which is no longer in operation.The manufacturing site will be listed as invacare invamex for filing purposes as they are the current manufacturing site for this device.The pictures provided didn¿t show any clear indication of damage to any of the bed components.However, the junction box ports did have some slight discoloration that the cause couldn¿t be determined.The junction box, actuators, power supply, and electronic cables are awaiting return, and if additional information becomes available a follow up medwatch will be filed.The underlying cause of the bed allegedly catching fire couldn¿t be determined.The reporter did indicate the device was plugged in via an extension cord, but the specifications of the extension cord were unknown.The device manual indicates ¿when using an extension cord, use only a three-wire extension cord having at least 16 awg (american wire gauge) wire and the same or higher electrical rating as the device being connected.Use of improper extension cord could result in a risk of fire and electric shock.Three prongs to two prong adapters should not be used.Use of three prong adapters can result in improper grounding and present a shock hazard to the user.¿ the bed is equipped with a hand crank to lower the bed down in the event of an electronic malfunction.
Event or Problem Description
The reporter stated the bar600ivc bed caught fire.They stated no injuries or damages were reported.This bed was in an assisted living facility and was confirmed to be plugged in via extension cord.According to the facility, the fire was near the junction box or the motors.

• Brand Name: IVC BARIATRIC BED 9153641598
• Common Device Name: BED, AC POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: mike simmons ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 21245641
• Report Number: 9616091-2025-00002
• Device Sequence Number: 18266618
• Product Code: FNL
• UDI-Device Identifier: 00841447102687
• UDI-Public: 00841447102687
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: NA:BAR600IVC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown