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 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Event Description

Arjo became aware of the nimbus mattress malfunction.The customer staff claimed the mattress over-inflation.The issue was detected at the time of preparing the device for use (after inflation).No patient was involved.No injury was claimed.

Manufacturer Narrative

Arjo became aware of the nimbus 4 mattress malfunction.The customer staff claimed the mattress over-inflation.The issue was detected at the time of preparing the device for use.No patient was involved.No injury was claimed.The involved device was excluded from use and returned to arjo.The nimbus mattresses consist of a top cover which covers the mattress support surface consisting of the sheet with air-filled cells under which is located the automatt sensor pad (mattress base).The claimed mattress over-inflation was caused by the automatt sensor pad failure.Based on the results of the mattress evaluation, the cause of the mattress base failure was an incorrect circulation of the air in the automatt sensor pad.The failure was caused by a damaged inner tube of the automatt sensor pad.The tube is made of tpu (thermoplastic polyurethane) and is responsible for transporting the air to the automatt sensor pad.When the tube cracks, the air is accumulated in a sealed automatt sensor pad cover, causing its over-inflation.The analyzed issue (automatt over-inflation) was addressed by the field safety corrective action (fsn-suz-001-2021, resh#87752) that has been already completed on the us market.In summary, the mattress was faulty and from that perspective, the nimbus mattress did not meet the performance specification.No patient was involved when the issue occurred.The complaint was decided to be reportable due to the automatt sensor pad failure causing over-inflation and risk for serious injury.

• 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: 15714114
• MDR Text Key: 302840089
• Report Number: 3005619970-2022-00025
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982782234
• UDI-Public: (01)05055982782234(11)151217
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• 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: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RESH#87752
• Patient Sequence Number: 1
• Patient Outcome(s): Other