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 Laceration(s) (1946)

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

Event 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.

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.

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
• 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
• 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
• MDR Text Key: 315473806
• Report Number: 3005619970-2023-00009
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982782234
• UDI-Public: (01)05055982782234(11)20170320
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 650001DAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2023
• Date Device Manufactured: 03/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male