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

Model Number 630EUR

Device Problems Electrical /Electronic Property Problem (1198); Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  Injury  

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).Arjo was informed about an event involving arjo auto logic system.The nurse stated that the customer staff felt a smell smoke and found soot on the footboard and duvet caused by a damaged mains cable.No injury nor other medical consequences were reported to arjo.Following the event, the pump was inspected by the arjo service technician.It was found that the isolation of the power cord was damaged.According to the instruction for use (630900en rev.7 from may 2011), arjo strongly recommends to ¿make sure that the mains power cable (.) are clear of moving bed mechanisms or other possible entrapment areas." as per instruction for use mains cable should be carefully inspected.When any malfunction is noticed, the device should be immediately withdrawn from the use until the service is performed.The complaint was decided to be reportable due to malfunction of the power cord which resulted in smell smoke and traces of soot.The power cord was found to be damaged and from that perspective, the device did not meet performance specification.The device was in use by the patient when the malfunction occurred.No injury or other medical consequences were reported.

Event Description

Arjo was informed about an event involving arjo auto logic system.The nurse stated that the customer staff felt a smell smoke and found soot on the footboard and duvet caused by a damaged mains cable.No injury nor other medical consequences were reported to arjo.

Manufacturer Narrative

Arjo was informed about an event involving an arjo auto logic system.A nurse stated that a customer staff felt a smell smoke and found soot on a footboard and duvet caused by a damaged mains cable.No injury nor other medical consequences were reported to arjo.Following the event, the customer was visited by an arjo service technician who picked up the pump (serial number (b)(6)), which was thought involved in the reported issue.On 22-oct 2020, after a follow-up contact with the customer representative we became aware that the pump with serial number (b)(6) was picked up by mistake.The correct serial number involved in the incident is (b)(6).The technician is no longer an arjo employ therefore we cannot explain how this mistake occurred.The condition of the picked up device and the results of the evaluation were in line with the event description, therefore we were convinced that the evaluation was performed on the correct device.We clarified that the involved pump (1300051760) was still available for a further investigation therefore we collected the pump on 23-oct-2020.The evaluation of the involved pump, revealed a presence of fluid/blood inside the plug holder which caused a short circuit and a power outage in a ward.The plug became melted.It is unknown in which circumstances the fluid ingress occurred.According to the instruction for use (630900en), arjo recommends to: ¿keep the pump away from sources of liquids and do not immerse in water.¿ ¿avoid immersing electrical parts in water during the cleaning process.Do not spray cleaning solutions directly onto the pump.¿ the complaint was decided to be reportable due to malfunction of the power cord which resulted in smell smoke and traces of soot.The power cord was found to be damaged and from that perspective, the device did not meet performance specification.The device was in use by the patient when the malfunction occurred.No injury or other medical consequences were reported.

• 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: 10132190
• MDR Text Key: 194443207
• Report Number: 3005619970-2020-00009
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

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
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/09/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other