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 Pressure Sores (2326)

Event Date 02/10/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, a malfunction of auto logic pump was reported to arjo by the customer representative.After receiving the communication about the malfunction occurrence, an arjo representative was dispatched to pick up the faulty pump ((b)(4)) and deliver new device ((b)(4)).At that time there was no indication that any injury occurred.On (b)(6) 2021, arjo received an adverse incident report ((b)(6)) from (b)(6) suggesting that a patient developed dti to left foot due to malfunction of auto logic system.According to information provided by the initial reporter, the auto logic mattress deflated overnight and when replaced second mattress also deflated.The patient was transferred on other device (atmosair mattress) until replacement was available.In the report submitted by the customer, (probably due to error) incorrect serial number of the involved pump was provided.The device involved in the reported incident was (b)(4), not as it was mentioned by the customer (b)(4).It was also clarified that the one mattress deflated, not two at it was stated by the customer.The second system is still in use in the customer facility as it was not malfunctioned.

• 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: 11480630
• MDR Text Key: 250643733
• Report Number: 1419652-2021-00006
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784283
• UDI-Public: (01)05055982784283(11)160727
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 630EUR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2021
• Distributor Facility Aware Date: 02/17/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention