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

Model Number 300502

Device Problem Material Puncture/Hole (1504)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Type  Injury  

Event Description

Following the information provided the patient was placed on the fluidair elite bed when the silicone beads that fill the bed, spreaded out into the air, landing on the patient's body and on the floor.The staff observed a small puncture in the bed cover sheet of an unknown origin.The outcome to the patient is unknown at this time.

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

Manufacturer Narrative

The fluidair elite bed was returned to the rental service center and the following findings were made.Two holes were found in the filter sheet (bottom layer).When the bed fluidization is activated it can cause the beads to migrate between the filter sheet and cover sheet (bottom layer and top layer).The bead migration was evident as there were beads located between the velcro seams, where the attachment of the sheets is located under the inner and outer extrusions (of perimeter clamp) and top extrusion that locks the sheets in place to the frame.When the bed was retrieved from the customer facility, it was noted that the inner and outer extrusions (of perimeter clamp) were not attached to the bed frame rim, which would result in beads being forced out between the filter sheet and cover sheet, subsequently spreading on top of the cover sheet, and outside the bed frame, especially when the fluidization is activated.This would explain the customer¿s depiction of the beads coming out from the bed and spreading to the floor.It is unknown how the extrusions became detached.It is possible for the extrusions to become dislodged, if they are used to push or pull the bed frame, or due to tension on the filter and cover sheets.The bed quality check was reviewed, and there was no evidence of functionality failure of the device prior to patient placement.The customer stated that the sheet "could have been torn by a chest film plate¿.The fluidair user manual (300510-ah) includes the following information related to the subject of the investigation: "filter sheet condition and microsphere containment - the filter sheet helps to regulate the fluidizing air flowing up through the microspheres and also helps to contain the microspheres within the tank.The following procedures should be followed to ensure microsphere containment: cover sharp edges of x-ray cassette with a pillowcase or other linen to avoid damaging filter sheet, inspect filter sheet regularly for damage, wear or any other evidence of unserviceability.Repair or replace immediately if integrity of filter sheet is compromised." "microsphere siplls - microspheres spilled on the floor may be slippery.Any microspheres on the floor or other exposed surfaces should be wiped up immediately using a damp mop or cloth." the user manual also instructs the user to pause the fluidization for the period of taking x-ray.In summary, considering the results of inspection and photographic evidence provided, the most likely cause of the beads leakage is combination of possible filter sheet damage by chest film plate and improperly sealed perimeter clamp.Arjo device failed to meet its performance specification since the filter sheet was damaged and perimeter clamp was improperly sealed, resulting in leakage of beads.The device was used for a patient treatment when the failure occurred.This complaint is deemed reportable due to allegation of a serious insult to an already life-threatening situation (possible contamination to wounds on a person who has 80% burns).Please note that previous medwatch reports for this product may have been submitted under the following registration number: (b)(4).Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration#: (b)(4).

Event Description

Following the information provided the customer depicted that there was a "literal explosion of silicone beads from underneath the patient with no detectable cause".The customer noticed a "microscopic tear in the sheet" of an unknown source, that allegedly "happened in the middle of the afternoon", the same day.The customer indicated that "it could have been torn by the chest film plate, but that was hours prior to finding this".At the time of event the patient with burns on 80% of the body was placed on the bed.The patient could not tolerate foreign matter contamination in his injuries.The customer stated that the patient was on this bed for 4-5 days prior to the event.The beads that spilled from the air fluidizing bed covered also the floor, which made it slippery and difficult to clean.

• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 14753958
• MDR Text Key: 294607251
• Report Number: 3007420694-2022-00095
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 07/20/2022
• 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): Other