MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number PXB001DAR

Device Problem Decrease in Pressure (1490)

Patient Problem Injury (2348)

Event Date 09/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo was notified about an incident involving the auto logic 200 mattress.It was reported that a patient developed pressure injuries since being on the arjo mattress.The auto logic mattress was installed on (b)(6) 2018 and on (b)(6)2018 the customer reported that it was not functioning correctly as it kept sinking in the middle when the head of the bed was raised and sometimes when the patient was repositioned it would sink on the sides.It was reported by arjo technician that the pump activated an alarm but the customer muted or reseted it by switching it off and on.During mattress inspection it was found that the mattress had a leak, therefore was replaced.We report this event in abundance of caution as information received suggests that although product which malfunctioned was alarming as per desing, it was still in used and the alarm was ignored by caregivers for unknown period (possibly 9 months).

Manufacturer Narrative

This report is being filed under exemption e2012066 by the getinge suzhou ltd (registration #3005619970) on behalf of the importer arjohuntleigh inc (ahus) (registration #1419652).We are still collecting data associated with the event.As soon as the information is available and investigation can be completed, the follow-up report will be provided.

Manufacturer Narrative

Investigation was carried out onto this complaint and the conclusions are following.Customer reported that the patient/resident sustained pressure ulcer since being on arjo auto logic mattress and that the system was alarming and the mattress was flat.The customer reported that it was not functioning correctly as it kept sinking in the middle when the head of the bed was raised and sometimes when the patient was repositioned it would sink on the sides.The customer alleges that they neither received product instruction for use nor demonstration provided on how to use the product, they were not aware that the system was not working as it should.The auto logic mattress was installed on (b)(6, 2018, the injury was noticed around (b)(6) 2018 and the customer reported the issue on (b)(6) 2018.Upon arjo technician visit to the customer, the mattress was found having a leak, thus it was replaced.Before the technician left, he made sure the system is working correctly under the patient.The customer was shown and educated how to operate the equipment.The faulty mattress was later evaluated and it was found that the mattress had a manifold connector assembly cracked.The faulty part was replaced, mattress was tested and returned to the rental fleet without further issues.The customer did not receive trainings in the past.According to the rental supervisor, who delivered the mattress, the customer had set up of the mattress and pump offered but refused because the patient was in the bed and the customer stated that they would install the system themselves later when the carer arrived.The customer was advice to contact the supervisor in case any troubles.Before rental supervisor delivered the auto logic system, she had called to ask if it was a good time to deliver the equipment.Auto logic system is equipped with an alarm.If the system senses low pressure in the mattress, a yellow indicator illuminates on the top of the pump and an audible warning sounds.An audible alarm sounds unless silenced by the alarm mute button.The customer confirmed there was an alarm, but the customer muted or reset it by switching the pump off and on.This visual and audible indicators are visible warnings.As soon as the alarm is heard or seen carers can call for arjo support.Failure of manifold assembly is not considered safety related as there are mitigation factors in place, such as low pressure alarm which warns caregiver to perform an action.It is unknown when the failure occurred and how long the alarm was ignored.The injury was noticed around september 30th and the customer reported the fault over a month later.The auto logic system is indicated for the prevention and/or management of all categories of pressure ulcer, but when combined with an individualized, comprehensive pressure ulcer protocol: for example repositioning, nutritional support, skin care.The system represents one aspect of a pressure ulcer management protocol; all other aspects of care should be considered by the prescribing clinician.According to arjo mobility gallery classification, the resident's class was e-emma, meaning this resident/patient is incapable of performing daily activities independently or actively contributing to them.Based on the above, the root cause of pressure ulcer cannot be defined.We have not found link between the auto logic mattress performance and patient injury.There are different factors which might lead to developing a pressure ulcer.Patients nutrition, overall health, comorbidities, surface, turning schedule, microclimate will all contribute to the development of pressure injury.The arjo auto logic system was used for patient treatment when the event occurred and therefore played role in the incident.The mattress had a component failure and from that perspective it did not meet the manufacturer specification, yet the system activated warning as designed.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. wawrzyniaka 2; komorniki, 62-05 2, P; PL 62-052, PL
• MDR Report Key: 8132913
• MDR Text Key: 129618147
• Report Number: 3005619970-2018-00014
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PXB001DAR
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2019
• Distributor Facility Aware Date: 11/09/2018
• Device Age: 3 YR
• Event Location: Home
• Date Report to Manufacturer: 02/01/2019
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 11/09/2018; 11/09/2018
• Supplement Dates FDA Received: 01/03/2019; 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other