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

Model Number TO BE DETERMINED

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

Arjo became aware of the event resulting in patient¿s stage 4 pressure injury development.The customer reported that the nimbus 4 mattress deflated at the sitting area and the pump¿s alarm did not activate.The patient was not supported properly enough and was almost lying on the bed frame.The mattress deflation was also observed when the transport mode was turned on.Moreover, the customer reported signs of wear on the mattress.The mattress was taken out of use and is awaiting for the inspection.

Event Description

Arjo became aware of the event resulting in patient¿s stage 4 pressure injury development.The customer reported that the nimbus 4 mattress deflated at the sitting area and the pump¿s alarm did not activate.The patient was not supported properly enough and was almost lying on the bed frame.The mattress deflation was also observed when the transport mode was turned on.Moreover, the customer reported signs of wear on the mattress.The mattress was taken out of use and inspected.

Manufacturer Narrative

The system was returned to arjo and inspected.It revealed leakage from the automatt assembly (part of the mattress) and from the pump¿s compressor.Moreover pump¿s power cord was damaged.Currently we are in the process of gathering and analysing the data in order to conclude the cause of the patient injury.

Event Description

Arjo became aware of the event resulting in patient¿s stage 4 pressure injury development.The customer reported that the nimbus 4 mattress deflated at the sitting area and the pump¿s alarm did not activate.The patient was not supported properly enough and was almost lying on the bed frame.Moreover, the customer reported signs of wear on the mattress.The mattress was taken out of use and inspected.

Manufacturer Narrative

The system was returned to arjo and inspected.It revealed leakage from the automatt assembly (part of the mattress) and from the pump¿s compressor.Moreover pump¿s power cord was damaged.The customer claimed that there was no low pressure alarm when the mattress deflated.The pump was made in 2016, which means that it uses the old mechanical low-pressure detector.There is a micro-switch in the pressure control assembly (pn 151059).If the pressure is not high enough (6~7 mmhg) to hold the micro-switch, the micro-switch will be released and the signal will be detected by the pump to present a low-pressure alarm.There is no doubt that the mattress failed its specification since it was deflating, however, the development of a serious pressure injury could be caused by the patient's condition.Nimbus 4 instruction for use 649933en states that the ¿system are indicated for the prevention and/or management of all categories of pressure ulcer, when combined with an individualised, comprehensive pressure ulcer protocol: for example, repositioning, nutritional support, skin care.¿ ¿the system represents one aspect of a pressure ulcer management protocol; all other aspects of care should be considered by the prescribed clinician¿.Currently we are in the process of analysing the data in order to conclude the cause of the patient 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: 19048739
• MDR Text Key: 339430003
• Report Number: 3005619970-2024-00009
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TO BE DETERMINED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/04/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 63 KG