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

Model Number 649STD

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 11/13/2022

Event Type  Injury  

Event Description

It was claimed by the customer representative that the "multiple nimbus mattress malfunctions for several days" resulted in stage iv pressure injury for a patient entered with healthy skin.The involved device was excluded from use and returned to arjo.

Manufacturer Narrative

Follow-up report was submitted to add more detailed description and add patient's weight.

Event Description

It was claimed by the customer representative that the multiple nimbus mattress malfunctions for several days resulted in stage 4 sacral bedsore for a patient entered with healthy skin.The conducted investigation allowed to clarify that the patient developed stage 4 sacral bedsore at the time of use of the nimbus system consisting of the mattress serial number (b)(6) and the pump serial number (b)(6).This system was installed on 9 nov 2022 and it was picked up on 12 nov 2022 as the customer claimed that the mattress was defective (allegedly had air leakage).

• 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: 15985063
• MDR Text Key: 305491842
• Report Number: 1419652-2022-00048
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784412
• UDI-Public: (01)05055982784412(11)211211
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 649STD
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2023
• Distributor Facility Aware Date: 11/21/2022
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 71 KG