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

Model Number 649015

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 10/30/2022

Event Type  Injury  

Event Description

On 13 jan 2023, arjo became aware of the second event that involved the same bedridden patient with very little mobility as in the medwatch ref.3005619970-2022-00032.This report refers to the event that occurred on (b)(6) 2022, the patient sustained a sacral ulcer with exposed underlying tissue.The patient used at that time the nimbus system that consisted of the nimbus pump serial number (b)(4) and the nimbus professional mattress serial number (b)(4).The patient¿s wound required daily monitoring using the bandages, the hydrofiber was applied after mechanical debridement.The system involved in the event was allegedly faulty, the customer staff informed about the pump failure and the mattress deflation.

Manufacturer Narrative

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

Manufacturer Narrative

During collecting the information for the event with arjo internal number (b)(4) (medwatch ref.3005619970-2022-00032) on (b)(6) 2023 arjo became aware that the same patient developed the serious injury (a sacral ulcer with exposed underlying tissue) while was laying on the nimbus system.The patient¿s wound required daily monitoring using the bandages, the hydrofiber was applied after mechanical debridement.The system involved in the event (pump (b)(6); mattress (b)(6)) was allegedly faulty, the customer staff informed about the pump failure and the mattress deflation.The evaluation of the claimed system conducted at the arjo service centre showed that the pump worked correctly but there was needed to replace few parts (front casing, blue pillow, grey gasket, silent bag, missing screw); the mattress had one faulty torso cell (weld failure) and a faulty leg elbow 1/2 hose.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.During the investigation, it was established that the patient developed the injury about 10 days before the arjo system was claimed as faulty.It is unknown whether the system malfunction occurred before the patient sustained the pressure injury.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.The instruction for use id.649933 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.¿ in the claimed event, it is unknown whether the therapy regimen has been adapted to the changing condition of the bedridden patient with very little mobility.Sum up, the arjo nimbus 4 system was used while the patient's condition deteriorated, therefore it played role in the event.The involved system was malfunctioned therefore it failed to meet its specification.It is unknown whether the therapy regimen has been adapted to the changing condition of the patient¿s which probably resulted in the pressure injury development.This complaint is deemed reportable following the customer statement indicating development of pressure injury, which has been deemed a 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: 16251966
• MDR Text Key: 308231417
• Report Number: 3005619970-2023-00002
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

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: Health Professional
• Device Model Number: 649015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2023
• Initial Date FDA Received: 01/27/2023
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2012
• 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