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

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 06/01/2023

Event Type  Injury  

Event Description

Arjo became aware of the event involving the nimbus 3 system.The customer alleged that the mattress deflation resulted in the patient¿s stage 4 pressure ulcer.The system was returned to the arjo and evaluated.It revealed 3 small holes in the mattress (in the heel guard, in the short cell and in the torso cell) and the small spilt in the compressor tubing.It caused that the mattress did not reach normal operating pressure.However, the revealed air loss did not cause mattress fully deflation and the low pressure alarm activation.The pump alarm was activated while the cpr was used causing the fully mattress deflation.The system was repaired and returned to the customer.

Manufacturer Narrative

Investigaition completion is ongoing.A supplemental report will be submitted when investigation is completed.

Manufacturer Narrative

When analysing currently available data we have learned, thus far, that the patient initially acquired an unstageable pressure ulcer to sacrum and then it changed to stage 4 pressure ulcer (intact deflated blister to left buttock).The leakage in the system did not result in mattress deflation.An alarm was working as intended.Currently we are in the process of analysing the gathered data in order to conclude the cause of the patinet injury.Once the investigation conclusion is available, the supplemental report will be submitted.

Event Description

The customer alleged that the mattress deflated.On 7 sep 2023 arjo was informed that the patient who was using the system sustained a serious injury.The patient initially acquired an unstageable pressure ulcer to sacrum and then it changed to stage 4 pressure ulcer (intact deflated blister to left buttock).When the system returned to the arjo service center it was quality control checked.The control, which is part of the standard rental process, revealed 3 small holes in the mattress (in the heel guard, in the short cell and in the torso cell) and a small spilt in the compressor tubing.These failures did not cause the mattress to deflate.When the system was tested by an arjo service technician, it was confirmed that the alarm was working as intended.The alarm activated when the cpr was opened and the mattress fully deflated.The system was repaired and returned to the customer.

Manufacturer Narrative

The product inspection and the test with weights on the mattress were performed.It revealed that although the system had some failures, these failures did not lead to the mattress deflation, which means that the patient was still supported by the surface.Moreover, performed tests showed that the alarm was working properly.The nimbus 3 instruction for use (ifu 151996en rev ¿) 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 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.¿ multiple factors could influence a patient¿s outcome, such as advanced age, immobility, co-morbidities, microclimate, nutrition, incontinence, lack of repositioning frequently enough.Therefore, we did not find a link between the mattress and the patient¿s injury.The arjo nimbus 3 system was used while the patient sustained a serious pressure injury, therefore it played a role in the event.The involved system malfunctioned therefore it failed to meet its performance specification, however, no link between the device and the patient outcome was found.The complaint was assessed as reportable due to the indication that the patient developed a serious pressure injury while lying on the arjo system.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17867489
• MDR Text Key: 324869959
• Report Number: 3005619970-2023-00023
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 60 KG