MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 151010

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 06/15/2022

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, these products are to be handled by arjohuntleigh ab¿s complaint handling establishment and any medwatch reports will be submitted under registration (b)(4).On (b)(6) 2022, arjo was notified, at time of pick-up of the nimbus 3 system that a condition of patient¿s who was using the system had deteriorated due to alleged system breakdown (not pumping up, not alarming).The patient had documented history of deteriorating pressure injuries.At time of pick up the system, he had pressure injury category unstagable to sacrum and left buttock and category 2 to right buttock.He required a treatment with a careful hygiene regime, dressings and repositioning.During the investigation we have learnt that, the involved nimbus 3 system was installed on 31 may 2022 by the arjo representative.There were no breakdowns reported between 31 may 2022 up to 14 jun 2022.During the interview with the patient, he recalled being uncomfortable for hours through the night but he did not inform the nurses about it.The claimed system was evaluated.The pump was inspected and no fault was found.The inspection of the mattress revealed a leakage of air from the split connection between one of cells and the vent valves.According to technician assessment, it was impossible to determine if the part failed due to the age or if it was mechanically damaged.This system is equipped with a sophisticated alarm system which differentiates between normal operation and genuine system faults.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 system detects lower pressure in the mattress.The instruction for use id.151996en states that one of the key factor in patient care is a patient¿s skin care management protocol and that if the patient¿s condition changes a therapy should be reviewed.¿the nimbus 3 systems are indicated for the prevention and management of all categories of pressure ulcer when combined with an individualised monitoring, repositioning and wound care programme.Systems represent one aspect of a pressure ulcer management strategy; if existing wounds do not improve or the patient¿s condition changes the overall therapy regimen should be reviewed by the prescribing clinician.¿ we were informed that the patient had pressure injuries before he was placed on the nimbus 3 system and that the patient's pressure ulcers had been deteriorating for the last few days.It is unknown whether the therapy regimen has been adapted to the changing condition of the patient¿s.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 arjo nimbus 3 system was used while the patient condition deteriorated, therefore it played role in the event.The involved system was malfunctioned therefore it failed to meet its performance specification.The complaint was assessed as reportable due to indication about the serious injury.

Event Description

On (b)(6) 2022, arjo was notified, at time of pick-up of the nimbus 3 system that a condition of patient¿s who was using the system had deteriorated due to alleged system breakdown (not pumping up, not alarming).The patient had documented history of deteriorating pressure injuries.At time of pick up the system, he had pressure injury category unstagable to sacrum and left buttock and category 2 to right buttock.He required a treatment with a careful hygiene regime, dressings and repositioning.

• Brand Name: NIMBUS 3 / DFS3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer (Section G): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton hall business park; houghton regis, bedfordshire LU5 5 XF; UK LU5 5XF
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 14985614
• MDR Text Key: 295687824
• Report Number: 3005619970-2022-00012
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2022

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: 151010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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 Age: 74 YR
• Patient Sex: Male