MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. NIMBUS 3 / DFS3; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 152010DAR

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 07/09/2022

Event Type  malfunction  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4) and (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).The customer staff reported that a patient was put on a nimbus 3 mattress which after some time deflated and no alarm was triggered by the pump.The patient sustained the category 2 pressure injury to the sacrum when was laying on the deflated nimbus 3 mattress over weekend (b)(6) 2022).During the investigation we have learnt that the involved patient (47 years old female) had multiple issues including multi organ failure, emphysema and sepsis.The patient was fully sedated and ventilated so she was too unstable due to clinical severity to be transferred on other device.The customer staff replaced the pump to re-inflate the mattress but the problem with deflation was not resolved.The faulty mattress was swapped out on (b)(6) 2022 when the patient¿s condition improved.The inspection of the mattress revealed a leakage of air from the split connection between one of torso 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.The both pumps used with the claimed mattress were also inspected and no faults were found.Nimbus 3 system is equipped with a sophisticated alarm system which differentiates between normal operation and genuine system faults.The alarm system worked correctly at time of evaluation both pumps, which means that if an alarm situation was detected an indicator would illuminate on the 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.(b)(4) 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.¿ 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.In the analysed case, the patient clinical condition did not allow on repositioning.The arjo nimbus 3 system was used while the patient condition deteriorated, therefore it played role in the event.The mattress was malfunctioned therefore it failed to meet its performance specification.This complaint was assessed as reportable in abundance of caution due to indication that the deflated nimbus 3 mattress remained in use for 2 days because transfer of the patient was impossible and the patient sustained a pressure injury.

Event Description

The customer staff reported that a patient was put on a nimbus 3 mattress which after some time deflated and no alarm was triggered by the pump.The patient sustained the category 2 pressure injury to the sacrum when was laying on the deflated nimbus 3 mattress over weekend (b)(6) 2022).

• Brand Name: NIMBUS 3 / DFS3
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15128076
• MDR Text Key: 304716562
• Report Number: 3005619970-2022-00013
• 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
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 152010DAR
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2013
• 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): Other
• Patient Age: 47 YR
• Patient Sex: Female