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

Model Number 649STD

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 11/13/2022

Event Type  Injury  

Manufacturer Narrative

The involved device was excluded from use and returned to arjo.The system was inspected and no fault was found.The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Event Description

It was claimed by the customer representative that the "multiple nimbus mattress malfunctions for several days" resulted in stage iv pressure injury for a patient entered with healthy skin.

Manufacturer Narrative

The investigation is still ongoing and no root cause has been established yet.The involved system was inspected and no fault was found.We are waiting for additional information from the customer to establish the cause of the claimed issue.

Manufacturer Narrative

It was claimed by the customer representative that the multiple nimbus mattress malfunctions for several days resulted in stage 4 sacral bedsore for a patient entered with healthy skin.The conducted investigation allowed to clarify that the patient developed stage 4 sacral bedsore at the time of use of the nimbus system consisting of the mattress serial number (b)(6) and the pump serial number (b)(6).This system was installed on (b)(6) 2022 and it was picked up on (b)(6) 2022 as the customer claimed that the mattress was defective (allegedly had air leakage).The evaluation of the claimed system conducted at the arjo service center showed that the system was working properly and no faults, nor air leaks were found.The alarm system worked correctly, which means that if an alarm situation was detected an indicator would illuminate on the top and front of the pump and an audible warning would be heard.The alarm system activates after the system detects lower pressure in the mattress.Based on the results of the system evaluation, the customer allegation could not be confirmed.Pressure injuries are complex and are a result of many factors including advanced age, immobility, co-morbidities, microclimate, incontinence, and lack of being turned or repositioned frequently enough.On 13 jan 2023, we were informed that the patient was assessed by the doctor as the bedridden patient with very little mobility.The patient had pressure injuries before the patient was placed on the nimbus system that is subject of this report.It is unknown whether the therapy regimen has been adapted to the changing condition of the patient¿s therefore the root cause of the claimed event could not be established.The instruction for use id.(b)(6) states that one of the key factors in patient care is a patient¿s skin care management protocol and that if the patient¿s condition changes therapy should be reviewed.¿the nimbus (¿) systems 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.Selection should be based upon a holistic assessment of the patient¿s individual care needs.These systems represent one aspect of a pressure ulcer management protocol (¿) if existing wounds do not improve or the patient¿s condition changes the overall therapy regimen should be reviewed by the prescribing clinician.¿ the arjo nimbus 4 system was used while the patient condition deteriorated, therefore it played role in the event.The involved system was allegedly malfunctioned as the customer claimed air leaking therefore it failed to meet its specification at the time of the event.Based on the results of system evaluation, the customer allegation could not be confirmed, the system worked correctly during the inspection.The complaint was assessed as reportable due to the indication of the 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: 15985062
• MDR Text Key: 305492503
• Report Number: 3005619970-2022-00032
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784412
• UDI-Public: (01)05055982784412(11)211211
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2023

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: Other
• Device Model Number: 649STD
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 11/21/2022; 11/21/2022
• Supplement Dates FDA Received: 01/11/2023; 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• 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): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 71 KG