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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information was provided as the involved mattress was returned to arjo on 12 oct 2022 what allowed to establish model number and serial number.

• 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
• MDR Report Key: 15389653
• Report Number: 1419652-2022-00040
• Device Sequence Number: 14902233
• 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: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/02/2022
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/03/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male
• Date Report Sent to FDA: 11/03/2022