MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. NIMBUS 4; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number	650001DAR
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/28/2022
Type of Reportable Event	Death
Event or Problem Description
Arjo became aware of an event involving a nimbus 4 mattress.A paraplegic patient fell out of the mattress and was found on the floor.He was lifted back into the bed using the hoist.The patient's condition had progressively deteriorated and the patient passed away.
Additional Manufacturer Narrative
We are waiting for access to the involved device to confirm the alleged mattress malfunction (overinflation) and to confirm cause of the event.The investigation is ongoing.Results of the analysis will be provided to the follow-up report.
Additional Manufacturer Narrative
The investigation is still ongoing.The return of the mattress was organized but it has not been delivered yet.We are waiting for the return of the mattress to confirm the alleged mattress malfunction (overinflation) and to confirm cause of the event.Results of the analysis will be provided to the follow-up report.
Additional Manufacturer Narrative
Arjo became aware of an event involving a nimbus 4 mattress.According to the report forwarded by the police to arjo, a paraplegic patient fell out of the mattress and was found on the floor.He was lifted back into the bed using the hoist.The patient's condition had progressively deteriorated and the patient passed away.The nimbus mattresses consist of a top cover which covers the mattress support surface consisting of the sheet with air-filled cells under which is located the automatt sensor pad (mattress base).Based on the photographic evidence provided, the mattress was over-inflated what contributed to the patient fall from the device.The involved mattress was returned to arjo on 12 oct 2022 and inspected the same day.Based on the results of the mattress evaluation, the cause of the mattress base failure was an incorrect circulation of the air in the automatt sensor pad.The failure was caused by a damaged inner tube of the automatt sensor pad.The tube is made of tpu (thermoplastic polyurethane) and is responsible for transporting the air to the automatt sensor pad.When the tube cracks, the air is accumulated in a sealed automatt sensor pad cover, causing its over-inflation.The analyzed issue (automatt over-inflation) was addressed by the field safety corrective action (fsn-suz-001-2021, resh#87752) that has been already completed on the us market.In summary, the mattress was faulty and from that perspective, the nimbus mattress did not meet the performance specification.The reported issue occurred when the device was used by the patient, therefore, the arjo product was directly involved in the reported incident.The complaint was assessed as reportable due to the patient fall from the mattress resulting in death.

• Brand Name: NIMBUS 4
• 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: 15389655
• Report Number: 3005619970-2022-00018
• Device Sequence Number: 5809391
• Product Code: FNM
• UDI-Device Identifier: 05055982782234
• UDI-Public: (01)05055982782234(11)160304
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2022

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
• Operator of Device: Other
• Device Model Number: 650001DAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 09/02/2022; 10/12/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 10/06/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RESH#87752
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male