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

Model Number UNKNOWN

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Event Description

Customer reported that they found an over-inflated mattress in the storage racks.There was no patient involvement and no injury.Gathering additional information is ongoing.

Manufacturer Narrative

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

Manufacturer Narrative

Gathering information is in progress.The conclusions are not available yet.The final report will be sent when the additional information is available.

Manufacturer Narrative

Arjo became aware of the nimbus 4 mattress over-inflation.The issue was detected at the time when the mattress was in the storage.No patient was involved and no injury occurred.The cause of the automatt overinflation is the incorrect circulation of the air in the automatt sensor pad (mattress base) due to a damaged inner tube.The tpu (thermoplastic polyurethane) tube may break over time due to the extruding force of the silicone tube and the external bending force, causing air accumulation in automatt.In summary, the nimbus 4 mattress did not meet its specification since the automatt sensor pad was faulty.No patient was involved when the reported issue occurred.No injury was claimed.The complaint was decided to be reportable due to the risk of patient¿s fall because the mattress was not corrected as per the field safety corrective action (tw1942837, fsn-suz-001-2021).

Event Description

Arjo became aware of the nimbus 4 mattress over-inflation.The issue was detected at the time when the mattress was in the storage.No patient was involved and no injury occurred.

Manufacturer Narrative

As for now, the customer did not share the details with arjo.Therefore, the conclusions are not yet available.When the investigation is completed, the result will be shared in the follow-up report.

• 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: 16867793
• MDR Text Key: 314552951
• Report Number: 3005619970-2023-00007
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RES 87752
• Patient Sequence Number: 1
• Patient Outcome(s): Other