MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. ALPHA TRANCELL DELUXE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	ATD001DAR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	02/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service manual (ser0005) states that "the mattresses can be used on standard hospital and normal domestic beds." in the alpha trancel deluxe (instruction for use (ifu / document no: (b)(4) ), there is warning: "alignment of the bed frame, safety sides and the mattress should leave no gap wide enough to entrap a patient's head or body.Care should be exercised to prevent occurence of gaps by compression or movement of the mattress.Death or serious injury may occur." the hypothesis that the mattress did not fit to the non-arjo bed due to its dimensions could not be verified as the dimensions of the bed frame are unknown.The root cause of the event could not be established.Arjo device was used for patient treatment when the event occurred and from that perspective played a role in the event.The customer has not reported an arjo device failure.The complaint was decided to be reportable due to the allegation of patient's entrapment which may result in serious injury.The device is distributed outside the us and no gudid information exists.
Event or Problem Description
Arjo was informed about the event involving the alpha trancell deluxe mattress.A customer reported that a patient's head became trapped between an arjo mattress and the side rail of a non-arjo bed.The patient had already indicated some pain symptoms, and she was physically deteriorating.The patient was found at 3 a.M.O'clock by the night shift.The patient was restless.The night shift placed the patient on her back.The patient sustained non-serious injuries to her face, arm, and leg.The mattress was inspected by an arjo technician, and no malfunction was found.The technician stated that the mattress was well positioned on the mattress base, however, the technician noted the space between the mattress and the bed side rail.The customer replaced the bed and the mattress.

• Brand Name: ALPHA TRANCELL DELUXE
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 21604228
• Report Number: 3005619970-2025-00008
• Device Sequence Number: 9601407
• Product Code: FNM
• UDI-Device Identifier: 05055982782265
• UDI-Public: (01)05055982782265(11)190403
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: ATD001DAR
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 49 KG