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	Laceration(s) (1946)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.
Event or Problem Description
The patient reported that the mattress overinflated and the patient fell from the mattress.There was no serious injury.The patient's sustained a laceration to the head which only required first aid measures.
Additional Manufacturer Narrative
The automatt of the nimbus 4 mattress overinflated when a patient was laying on the mattress.As a result, the patient fell from the mattress.The patient sustained a cut on the head (not a serious injury).The involved mattress was returned to the manufacturer for evaluation.During the manufacturer's inspection, it was found that the membrane holder relocated blocking the airflow.The relocation of the holder caused the overinflation of the automatt and subsequently the patient's fall.The simulation confirmed the customer¿s allegation.In summary, the nimbus 4 mattress did not meet its specification since the automatt sensor pad overinflated with the load applied.The reported issue occurred when the device was used by the patient.The patient involved sustained a non-serious injury.The complaint was decided to be reportable due to the patient's fall which could have led to serious health consequences.
Additional Manufacturer Narrative
The evaluation of the returned product was completed on (b)(6).Currently, all the gathered data are analysed.Once the final conclusions are available, the final report will be submitted.

• 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: 16937352
• Report Number: 3005619970-2023-00009
• Device Sequence Number: 14908652
• Product Code: FNM
• UDI-Device Identifier: 05055982782234
• UDI-Public: (01)05055982782234(11)20170320
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/30/2023

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: 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: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023; 04/20/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 08/02/2023; 08/30/2023
• Date Device Manufactured: 03/20/2017
• 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 Sex: Male