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

Model Number 300502-R

Device Problems Device Inoperable (1663); Temperature Problem (3022)

Patient Problem Injury (2348)

Event Type  Injury  

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 (b)(4).From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted.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.Additional information will be provided upon conclusion of the investigation.

Event Description

On 10th september 2017 arjohuntleigh representative was informed about fluidair failure.It was reported that the fluid air was alarming that an overheated condition occurred and shut down the blower resulting in the surface going firm.Because the issue continued the patient was taken off of the bed and placed on a hospital bed - linet frame and arjohuntleigh mattress - first step.The nurse alleged that the bed became hard and that contributed to the failure of the patient's flap.

Manufacturer Narrative

Investigation has been carried out and conclusions are following.Arjohuntleigh was informed about an event which occurred in (b)(6) hospital in (b)(6).It was reported that the alarm on fluidair elite bed had been activated.The alarm had been activated because the bed sensed an overheated condition as per design.The bed shut the blower off to cool the surface.While doing so, the surface became firm.The bed was ordered for a paraplegic patient who underwent flap and graft surgery.Because of a continuous alarm, the patient was moved from the fluidair elite and placed on non-arjohuntleigh bed - linet frame and arjohuntleigh mattress - first step.According to the nurse although the patient was at risk before being placed on fluidair elite, the issue they experienced with the arjohuntleigh bed allegedly contributed to patient's flap failure.According to an arjohuntleigh clinical consultant, the bed was at the facility for about 15 hours, however there is no information how long the patient was on the bed during that time.The bed was evaluated in the arjohuntleigh (b)(4) service center.A repair technician found small amount of dust at the blower intakes and seized one out of a cooling fan.No other failures have been identified.The repair technician indicated that the mentioned failures on its own would not create an overheated condition.The issue experienced by the customer could have been duplicated at service center.The bed turns off the blower in environmental temperature conditions over 105°f (40°c).When the temperature in the warehouse and outside dropped to 80°f and 90°f (26°c - 32°c) the problem could not have been duplicated.According to the service technician, (b)(6) area went through a long period of hot weather that time with temperature in the warehouse over 105°f (38°c) and the bed was not used often.Also at the day of the event, the area went through a heat wave.The bed was transferred from a warehouse in the box truck with the same heat conditions.Even if the facility has temperature controlled with air conditioning, according to a field repair technician it would be possible that "the beads would still retain their heat and could take a very long time for them to cool back down to an operational range." a combination of factors most likely resulted in the reported overheated condition: unusual high temperatures, seized fan and dust built in the blower.The device was working as intended, when the sensors sense high beads (microsphere) temperature, an alarm activated and the unit was automatically deactivated to cool down.Device user manual 300510-ah rev.C indicates that "if the unit senses an excessive microsphere temperature, an audible alarm sounds and the unit will automatically deactivate until the microsphere temperature drops.The caregiver should consider whether it is necessary to monitor the temperature of the patient at regular intervals." based on the above, it was determined that the overheated condition which led to hard bed surface, on its own, would not contribute to flap failure, a combination of several factors led to the reported incident: patient medical condition, unusual high temperatures, seized fan and dust built in the blower.In summary, the bed was used for a patient treatment when alarm condition occurred, several factors occurred that resulted in alarm condition, a direct relation of the device to patient's flap failure could not determined.The bed did not fail to meet its specification, it activated an alarm as designed.We report this incident due to indication of an injury (a serious injury) sustained and not due to product issue.Overheating condition on its own does not constitute the basis for complaint to be reportable to competent authority.

• Brand Name: FLUIDAIR ELITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: kinga stolinska ; ul. ks. wawrzyniaka 2; komorniki, 62-05-2, P ; PL 62-052, PL
• MDR Report Key: 6917034
• MDR Text Key: 88764727
• Report Number: 3007420694-2017-00205
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 300502-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization