MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. FLUIDAIR ELITE; BED, AIR FLUIDIZED

Model Number 300502-R

Device Problems Fire (1245); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetic concept inc (under registration #1625774).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #3009988881.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration #307420694.Additional information will be provided upon conclusion of the investigation.

Event Description

As reported by the customer, while attempting to put a patient on the bed, a hospital employee ran over the cord with a ventilator cart that damaged wires.A spark was noticed and then the power cord caught fire.Fire went out on its own.The patient was not on the bed.No injury reported.

Manufacturer Narrative

A photographic evidence of power cord was provided.Based on this, it could be stated that the power cord insulation was damaged and internal wires were exposed.The power cord insulation melted in small degree.Investigation is still in progress and additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

The investigation has been completed and conclusions are following.On 21 november 2017 an arjohuntleigh was notified about an incident with fluidair elite.A customer (b)(6) hospital reported that fluidair power cord was run over by a cart.According to the customer "a spark was noted by employee and then the cord caught fire causing about a 3 inch burn of the rubber and leaving a scorched mark on the floor.Fire went out on its own." the power cord was disconnected after the code red had been called and security personnel had arrived.There was no injury in relation to this even.When reviewing reportable complaints related to fluidair product range registered within the last 5 years, we have not found a similar issue.A photo evidence has been provided to arjohuntleigh electronic engineer for expertise.The expert indicated that in this complaint the power cord was run over by a cart, which caused a short circuit of neutral cable with phase cable, this resulted in melted insulation.The power cable met the criteria for ft2 because the insulation melted in small degree as per ft2 (8*) of canadian standard association (csa): "small scale flame tests: csa - minimum mandatory horizontal flame test for flexible cord (finished cable).(1700 btu -500w) a burner flame is applied to a horizontal sample for five 15 second applications and must not exceed 100 mm from end to end.There should also be no type of flame particles falling from the sample." it was stated by the customer that the fire went out on its own, which would confirm an expert's opinion that the power cable met the requirements for flame testing.The power cable insulation did not allow the fire to spread and extinguished it after some short time, minimizing any hazardous situation.User manual for fluidair elite 300510-ah rev.C warn to "ensure power cord is kept free from all pinch points and moving parts and is not trapped under casters nor covered with rugs or carpets.Visually inspect the cord for signs of damage or wear.Improper handling of the power cord can cause damage to the cord, which may possibly produce risk of fire or electric shock." "do not leave the unit plugged in with the main control panel deactivated.If the unit is to remain unused for an extended period, unplug the power cord from the wall outlet and wrap around the accessory support bracket to prevent cable damage." in summary, the power cord became damage in a way that sparks and fire was visible, because a customer employee run over the cord with ventilator cart.The power cord insulation design prevented from fire spreading and extinguished it, minimizing any hazardous situation.In that regards the bed met its performance specification.When the event occurred there was no patient treatment, but the bed played role in the incident as a hospital staff did not take due care during preparation for patient placement on fluidair bed and damaged the cord.The event occurred due to user error.We report this incident because of potentially hazardous situation due to fire occurrence.

• Brand Name: FLUIDAIR ELITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 7124526
• MDR Text Key: 95158398
• Report Number: 3007420694-2017-00229
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2018

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: Nurse
• Device Model Number: 300502-R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 11/21/2017; 11/21/2017
• Supplement Dates FDA Received: 04/02/2020; 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other