MAUDE Adverse Event Report: INVACARE FLORIDA SEMI ELECTRIC-SINGLE CRANK HI/LO BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5310

Device Problems Smoking (1585); Flare or Flash (2942)

Patient Problem No Patient Involvement (2645)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred while the bed was being serviced; there was no patient involvement.The dealer advised that the patient had alleged that none of the functions were working on the pendant, so he went to the facility to install a replacement.He stated that he plugged in the replacement pendant and began testing the functions.He indicated that the head up and down functions worked without issue, but when he was testing the foot section of the bed, it would only raise, not lower.He indicated that he tried pressing the foot down button on the pendant multiple times to try to get the foot section to lower, and then the junction box began smoking/flaming.He advised that he was not able to determine the specific origin of the smoke/flames, such as if they were emitting from one of the ports on the junction box where either the pendant or motors plug in.He alleged that the junction box continued to burn until he smothered out the flames with a small pillow.He stated that the smoke caused the fire alarm to be activated at the facility, so the fire department was called.The fire department deactivated the smoke alarm and checked everything over, confirming that nothing was still on fire.The dealer indicated that he did not notice any damage to the bed's wiring, and the pendant cord was not damaged.He stated that the bed was plugged directly into a 3-prong wall outlet, and he did not believe that anything else was plugged into the same outlet.He was unsure if the junction box was original to the bed or if it had been previously replaced.He advised that they do not perform routine maintenance of the bed; they only perform servicing as needed.It was confirmed that the dealer installed the correct invacare replacement pendant for the 5310 bed.The 5310 bed was manufactured in april 2000; therefore, it has exceeded its expected life of 7 years.Additionally, the 5310 model bed was obsoleted in (b)(6) 2003.At this time, the underlying cause of the junction box smoking/flaming cannot be determined.The dealer was asked that the product be returned to invacare so that it may be evaluated.However, he advised that they cannot remove the bed from the facility without their permission.He stated that they have reached out to the facility to let them know that invacare would like the product back; however, the facility has not yet decided what they are going to do as far as replacing it.He advised that if the facility decides to purchase a replacement from them, then they will retrieve the old bed and they would then be able to return the product to invacare.Should additional information become available, a supplemental record will be filed.

Event Description

The dealer reported that he installed a replacement pendant on the 5310 bed, and while testing the functions, the junction box emitted flames and smoke.

• Brand Name: SEMI ELECTRIC-SINGLE CRANK HI/LO BED
• 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 44035 ; 8003336900
• MDR Report Key: 8190186
• MDR Text Key: 131177190
• Report Number: 1031452-2018-00017
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/27/2018

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
• Device Operator: Other
• Device Model Number: 5310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2000
• 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