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

Model Number 630001

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

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).An investigation is ongoing, no final conclusions are available at this time.

Event Description

A service of an auto logic pump was requested by a customer due to issue with a power cord plug which allegedly sparking.No injury was reported.No medical intervention was needed.The device was excluded from use and picked-up by an arjo representative who found that the power cord insulation was damaged and observed brown mark on the pump casing.

Manufacturer Narrative

Arjo was informed by the customer, that they heard the noise and noticed sparks coming from the power cord plug of an auto logic pump.The patient was immediately removed from the bed and the pump was quarantined for inspection.No injury was reported.During the pickup of the pump from the customer, the arjo representative found that the power cord insulation was damaged and a brown flashpoint mark was observed on the pump casing.The power cord was cut to avoid further use and the pump was replaced by the new one.The customer representative was not able to provide any further details about the circumstances in which the power cord was damaged.According to the instructions for use (630900en), arjo strongly recommends: ¿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for use mains cable should be carefully inspected.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed.To sum up, the complaint was assessed as reportable due to damage to the power cord insulation that resulted in sparks.The power cord was found to be damaged and from that perspective, the device did not meet specification.There was a patient involved.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: 12195502
• MDR Text Key: 263390202
• Report Number: 3005619970-2021-00015
• 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: 08/11/2021

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: 630001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/03/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 07/03/2021
• Supplement Dates FDA Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other