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

Model Number	650201DAR
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A malfunction of the nimbus 4 system which consists of mattress (650201dar, serial number (b)(4)) and pump (unknown serial number) was reported to arjo by the customer staff.Following information gathered, it was observed that the mattress started overinflating after patient¿s repositioning.The patient was transferred to another device.No injury was reported.A cause of the reported issue was an incorrect circulation of the air in automatt sensor pad (mattress component).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 overinflation.In summary, the automatt sensor pad was faulty and from that perspective, the nimbus mattress did not meet the performance specification.The reported issue occurred when the device was used by the patient.No injury was reported.The complaint was decided to be reportable due to risk of patient¿s fall from the mattress.
Event or Problem Description
A malfunction of the nimbus 4 system which consists of mattress (650201dar, serial number (b)(4)) and pump (unknown serial number) was reported to arjo by the customer staff.Following information gathered, it was observed that the mattress started overinflating after patient¿s repositioning.The patient was transferred to another device.No injury was reported.

• Brand Name: NIMBUS 4
• Common Device Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• MDR Report Key: 11705077
• Report Number: 3005619970-2021-00010
• Device Sequence Number: 19806871
• Product Code: FNM
• UDI-Device Identifier: 05055982782258
• UDI-Public: (01)05055982782258(11)1610101
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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
• Operator of Device: Other
• Device Model Number: 650201DAR
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other