MAUDE Adverse Event Report: ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number PXB001DAR

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Customer informed that the mattress was very soft in the middle section.There was no injury in regards to this failure.After the initial test of arjo technician the dipping was confirmed.No low pressure alarm was noticed.Because further tests are needed, the mattress is to be sent to the manufacturer for evaluation.

Manufacturer Narrative

An investigation was carried out for this complaint with the following conclusions: a customer reported that an auto logic mattress was dipping in the middle.Initially, the customer stated the patient had markings on their skin.During a follow-up communication, the customer explained that the patient had already been suffering from pressure ulcer, stage 4 and the failure did not cause an injury.Customer staff indicated that the mattress was very soft around the middle section of the mattress and when they placed their hands in between the patient and the mattress they could feel the bed frame, however there was no alarm.Having this additional information, on june 10, 2019, arjo technician performed tests, which revealed that the mattress bottomed out in the middle section and an alarm was not heard.An arjo technician initial inspection revealed a leakage in one cell-in-cell of the mattress torso section.Pump was also evaluated and no failures were found.At this point it was decided to report the reported failure in abundance of caution and send the faulty mattress for further evaluation to manufacturer arjo (suzhou) co., ltd.The manufacturer found that mattress had three leakage points: mattress base pad, cell-in-cell and cell in head section.The three leak points caused that the air from one cell escaped through head cell, further through base pad and cell-in-cell to outside environment.The reported 14 years old autologic mattress variant 200, comprises of a mattress overlay on top of an air-filled sub-mattress (base pad).The air filled sub-mattress is kept at a constant pressure and in normal condition the pressure in the base pad, in case of overlay failure, will support patient as the pressure remains on 30 mmhg for patient comfort.In the reported complaint three leakage points together caused that mattress might not support patient.The autologic system represents one aspect of a pressure ulcer management protocol, all other aspects such as repositioning, nutritional support, skin care should be considered.Device instructions for use, document: (b)(4)· 01/2019, informs about it as following: "it is the responsibility of the care giver to ensure that the user can use this product safely"."the auto logic systems are indicated for the prevention categories and/or management of all of pressure ulcer, when combined with an individualised, comprehensive pressure ulcer protocol: for example, repositioning, nutritional support, skin care.Selection should be based upon a holistic assessment of the patient's individual care needs." in conclusion, arjo auto logic system was being used for treatment at the time of the event, thus played a role.It failed to meet its performance specification since the mattress had leaks and no alarm was triggered.There was no injury in regards to this issue and no adverse reaction was reported in the past.Although patient did not sustain or worse their preexisting injury, arjo has decided to report this event in abundance of caution due to the nature of the fault.

Manufacturer Narrative

Parts b3 and b7 were updated.Device was returned to manufacturer and currently is being tested.Additional information will be provided upon conclusion of the manufacturer's investigation.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB; arjohuntleigh house, houghton; houghton hall business park; houghton regis, LU5 5 XF; UK LU5 5XF
• MDR Report Key: 8743406
• MDR Text Key: 188870355
• Report Number: 3005619970-2019-00010
• 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: 10/11/2019

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: No Information
• Device Model Number: PXB001DAR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2019
• Distributor Facility Aware Date: 06/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: Not provided; 09/19/2019
• Supplement Dates FDA Received: 07/26/2019; 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other