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

Model Number 630009AU

Device Problem Electrical Shorting (2926)

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

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).During an inspection of an auto logic pump picked-up from wollongong hospital due to expiration of the rental period, it was found that the pump power cord was damaged.On the broken insulation was observed signs of burning marks.No injury neither cable failure was reported by the customer to arjo.A device inspection performed by an arjo representative revealed that the main power cable was physically damaged.It is unknown in which circumstances the damage occurred but based on the condition of the cable, it seems most probable that it was lying on the floor and was damaged by the bed castors or was stuck between the bed moving parts.According to the auto logic instruction for use (630933) user ¿make sure that the mains power cable and are positioned to avoid causing a trip or other hazard, and are clear of moving bed mechanisms or other possible entrapment areas.The mains power cable of this pump is designed to allow movement of the bed, and should be fitted into the cable management flaps along the sides of the mattress, as described in this manual.¿ the complaint was assessed as reportable due to sign of burning mark on the cable.The power cord was found to be damaged and from that perspective, the device did not meet specification.There was no indication that any patient was involved.No injury or other medical consequences were reported.

Event Description

During an inspection of an auto logic pump picked-up from wollongong hospital due to expiration of the rental period, it was found that the pump power cord was damaged.On the broken insulation was observed signs of burning marks.No injury neither cable failure was reported by the customer to arjo.

• 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
• Manufacturer (Section G): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 12073624
• MDR Text Key: 263390550
• Report Number: 3005619970-2021-00013
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784252
• UDI-Public: (01)05055982784252(11)140806
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 630009AU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other