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

Model Number 650001DAR

Device Problem Increase in Pressure (1491)

Patient Problem Fall (1848)

Event Date 08/28/2022

Event Type  Death  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 299548547
• Report Number: 1419652-2022-00040
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982782234
• UDI-Public: (01)05055982782234(11)160304
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 11/03/2022
• Distributor Facility Aware Date: 09/02/2022
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/03/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male