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

Model Number 630EUR

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

(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: 3005619970-2020-00006, 3005619970-2020-00007, 3005619970-2020-00008.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 or worse their preexisting injury as outcome of this event.

Manufacturer Narrative

Arjo was informed by the customer representative that the patient (94 years old female with pre-existing injury, a stage 4 sore) 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 activate a low pressure alarm.The patient did not sustain or worse their pre-existing injury as an outcome of the reported issue.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: 3005619970-2020-00006, 3005619970-2020-00007, 3005619970-2020-00008.The involved system (mattress and pump) was evaluated in the arjo service centre.No air leakage in the mattress or pump was found.During the pump evaluation it was found that the speaker did not work but the yellow low pressure indicator was functioning correctly.This failure did not cause an insufficient air supply to the mattress.As per design, the pump can inflate the mattress even if the speaker is defective when the pump is plugged in.Based on the above information, the cause of the mattress deflation cannot be confirmed.Device instructions for use, ifu 630933en rev.7 from apr 2018 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 categories and/or management of all of pressure ulcer, when combined with an individualized, 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.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 although a patient did not sustain injury.The system did not meet the performance specification.

• 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: 10095373
• MDR Text Key: 195713418
• Report Number: 3005619970-2020-00005
• 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: 630EUR
• 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: 94 YR