MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 630004FR

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

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).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 facility reported that the same issue occurred on 3 another arjo auto logic systems, so three additional reports were submitted under manufacturer report no: 3005619970-2020-00005, 3005619970-2020-00006, 3005619970-2020-00007.Collecting of information is ongoing.Results of the analysis will be provided to the follow-up report.

Event Description

Arjo was informed by the customer representative about arjo auto logic pump malfunction.Following the information reported, the patient was found by the facility staff between 3am and 4am that she stayed the night on the totally deflated mattresses (included sub-mattress).The caregiver found that the pump was turned off and did not activate a low pressure alarm to alert about malfunction.The patient did not sustain injury as outcome of this event.

Manufacturer Narrative

Arjo was informed by the customer representative about arjo auto logic pump malfunction.Following the information reported, the patient (88 years old female) was found, by the facility staff, between 3am and 4am on the totally deflated mattresses (included sub-mattress).The caregiver found that the pump was turned off and did not hear a low pressure alarm.The patient did not sustain an injury as an outcome of the reported issue.The facility reported that the same issue occurred on 3 another arjo auto logic systems, therefore three additional reports were submitted mfr report no 3005619970-2020-00005, 3005619970-2020-00006, 3005619970-2020-00007.The system (mattress and pump) was excluded from use and evaluated in arjo service centre.The mattress was tested and no issue was detected ¿ no air leakage was found.During evaluation of the pump it was found that the alarm battery was not working (it was replaced).The battery is only for power failure alarm.The pump can inflate even if the battery is defective.If the battery is defective, there will be an alarm light blinking on the pump when plugged in.The alarm battery does not impact work of the pump.A low pressure condition which occurred in the system cannot be confirmed as the system evaluation did not confirm the alleged issue, no air leakage was detected, therefore root cause cannot be established.Device instructions for use, ifu 630933 rev.9 from aug 2019 includes following information: ¿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 and/or management of all categories 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.¿ troubleshooting section defines also possible causes of low pressure and remedy: - the tubeset is not connected properly ¿ check the tubeset connector, - cpr not fully closed ¿ close cpr unit, - a leak in the system ¿ call service engineer.In conclusion, arjo auto logic system was being used for treatment at the time of the event.Arjo has decided to report this complaint due to the allegation that the patient stayed the night on the totally deflated mattress (included sub-mattress) and a low pressure alarm was not heard.Alarm battery was not working, and from that perspective the system did not meet the performance specification, but this failure will not result in an harm.Pump is still inflating the mattress when plugged in.There was no patient injury and is unlikely any serious injury occurs as a result of alarm battery failure.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• MDR Report Key: 10095568
• MDR Text Key: 241002986
• Report Number: 3005619970-2020-00008
• 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
• Report Date: 06/23/2020

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: 630004FR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 05/14/2020
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR