MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. MAXXAIR ETS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Physical Entrapment (2327)

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (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).An investigation is ongoing.No final conclusions are available at this time.

Event Description

An arjo account executive was informed by a customer representative about an issue involving a maxxair ets mattress and a citadel plus bed frame.It was reported that a patient got stuck between a bed side rail and a shifted mattress.No injury occurred as outcome of this event.

Manufacturer Narrative

Both maxxair ets mattress and citadel plus bed have the ability to expand their width in order to best suit the patient, but also to fit the mattress size to the frame width.The ifu for citadel plus bed (831.374 rev.F) informs the user as follows: ¿push in all width extensions prior to transport¿.The customer did narrow the bed as per the ifu recommendations.The width of the mattress should be always in line with bed width, therefore in the complained scenario the mattress should have been narrowed to 36 inches and adjusted to the bed during the transport.The ifu for maxxair ets 310115-ah rev.3 informs the user that the mattress width needs to be adjusted: ¿adjust width of mrs [mattress replacement system] as appropriate: - when using the 36 in.Wide bed frame, the expansion knob should be in line with 36 in.¿ in summary, the caregivers narrowed the bed frame as recommended by the ifu for citadel plus beds, but did not adjust the mattress width correspondingly, which led to shifting of the mattress out of the bed and patient¿s entrapment between the mattress and bed side rail as a result.At the time of the event the arjo device was in use with patient therefore it played a role in the reportable incident.The mattress or the bed did not show any deficiency at that time.

Event Description

Arjo received a complaint stating that the patient was transported to another floor, while being in citadel plus bed equipped with maxxair ets mattress.The facility staff narrowed the bed frame width to 36 inches (as instructed by the ifu for transport), but did not adjust the mattress width and kept it at 48 inches.As a result, the mattress, which was not secured with straps to the frame, shifted, causing the patient to become trapped between the mattress and the bed side rail.No injury occurred as a result of this event.

• Brand Name: MAXXAIR ETS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 11883079
• MDR Text Key: 264193368
• Report Number: 3007420694-2021-00076
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other