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

Model Number PXB001DAR

Device Problems Air Leak (1008); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Arjohuntleigh was informed about an event which occurred with the involvement of auto logic system.It was reported that a bedridden patient has fallen down from the mattress.Circumstances: a low pressure alarm on the pump unit was launched during the night.Caregivers tried to adjust (increase) pressure within the system with a comfort control buttons.According to the customer, the patient has fallen due to 'over-inflate' condition within the mattress.Barriers were in a lower position when the event occurred.

Manufacturer Narrative

This report is report is being filed under exemption e2012070 by (b)(4).An investigation was carried out into this complaint.On (b)(6) 2017 arjohuntleigh received information regarding an event which occurred with the involvement of auto logic system.It was reported that a bedridden patient has fallen down from the mattress after caregivers attempted to adjust a low pressure condition which occurred in the system.As a consequence the patient received a bruise localized at head.No medical intervention nor prolonged hospitalization was required as a result of the reported complaint.A review of similar reportable events has found a number of other cases regarding patient's fall, however, only one event included an allegation of mattress being overinflated.This allegation could not have been confirmed upon a comprehensive device inspection which revealed proper functioning of the device.The occurrence rate observed for this failure mode is very low.It was reported that a low pressure alarm was launched on the pump.Caregivers tried to adjust (increase) pressure within the system with comfort control buttons in order to compensate the air loss.It was indicated that barriers of the bed were in a lower position when the event occurred.The involved system was comprehensively tested by arjohuntleigh.The source of air leakage was identified to be located in a faulty cell, due to a broken connector welding.Although the mattress component malfunction occurred during the therapy, a low pressure alarm was operating properly, alerting the user of a detected low pressure condition.Results of pump inspection showed that the unit was working in accordance with the manufacturer's specification, no discrepancy in the device performance was noted.The allegation of mattress over-inflation was not confirmed.Even though caregivers tried to correct the pressure within the system manually, using comfort control buttons, the pressure may have only reached the particular, specified level, being still within the designed pressure range.Comfort control buttons are used to control the relative firmness/softness of the mattress, to meet individual patient's comfort.This feature is not designed to compensate air leakage in the event of component malfunction.In accordance with the instruction for use #630933en: "if the trouble shooting procedures do not return the system to normal performance, stop using the system immediately and call the service engineer." basing on the above, it appears that caregivers made an attempt to correct the malfunction not following the instruction for use indications.Side rails are designed to prevent unintentional exits/falls of passive patients and the decision on their usage should be based on individual assessment of patient's condition.The procedure of patient's care appears not to have been revised when circumstances of performed therapy were changed ( bed barriers remained in the lower position).It has been established that auto logic system was in use for a patient therapy at the time of the event.The mattress was found to have malfunctioned (not performing to specification) when the event took place, however, a design risk mitigation factor (low pressure alarm) was operating properly and successfully alerted the user of system fault.Our review did not identify any relation between device problem and patient's fall.We are reporting this event to competent authorities in abundance of caution, in regards to the indication of patient's fall.

• Brand Name: AUTO LOGIC
• 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: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 6868405
• MDR Text Key: 87307683
• Report Number: 3007420694-2017-00188
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: PXB001DAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2017
• Distributor Facility Aware Date: 08/28/2017
• Device Age: 9 YR
• Date Report to Manufacturer: 10/09/2017
• Date Manufacturer Received: 08/28/2017
• 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): Other
• Patient Age: 84 YR