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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

Event Type  malfunction  

Event Description

Arjo became aware of the nimbus 4 mattress over-inflation.The malfunction was observed by the customer¿s maintenance technician when the mattress was prepared for use.No patient was involved and no injury occurred.When the failure occurred, the field safety corrective action was not completed on the involved product.The mattress was taken out of use and quarantined.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.

Event Description

Arjo became aware of the nimbus 4 mattress over-inflation.The malfunction was observed by the customer¿s maintenance technician during preparing the mattress for use.No patient was involved and no injury occurred.When the failure occurred, the field safety corrective action was not completed on the involved product.The mattress was taken out of use and quarantined.

Manufacturer Narrative

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 ( fsn-suz-001-2021).

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17727020
• MDR Text Key: 323149094
• Report Number: 3005619970-2023-00019
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982782227
• UDI-Public: (01)05055982782227(11)20161022
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2016
• 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