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 10/05/2023

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.Date of event was estimated based on the awareness date.

Event Description

Arjo became aware of the nimbus 4 mattress over-inflation.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 over-inflation 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 involved mattress was not corrected as per the field safety corrective action (fsn-suz-001-2021) because the customer informed arjo on 14 december 2021 that the mattress could not be located.The complaint was assessed as reportable due to the mattress over-inflation caused by automatt sensor pad failure, which did not have correction completed.

• 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: 18065006
• MDR Text Key: 327277780
• Report Number: 3005619970-2023-00027
• Device Sequence Number: 1
• Product Code: FNM
• 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
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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
• Device Model Number: 650001DAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• 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