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

Model Number 650201DAR

Device Problem Increase in Pressure (1491)

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

Event Date 04/05/2021

Event Type  malfunction  

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 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
• 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 11705077
• MDR Text Key: 246695534
• Report Number: 3005619970-2021-00010
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982782258
• UDI-Public: (01)05055982782258(11)1610101
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: 650201DAR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other