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

Model Number 630004DK

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Following a visit at the customer site related to a complaint recorded under arjo internal number (b)(4) (medwatch#3005619970-2020-00009), a former arjo technician collected auto logic pump with serial number (b)(4).The technician was convinced that the pump in question was involved in the reported event.On 22 oct 2020, arjo became aware that the pump with serial number (b)(4) was collected mistakenly and the actual pump involved in the event had serial number (b)(4).Following this clarification a new complaint was recorded under arjo internal number (b)(4) to perform an investigation related to failure of pump with serial number (b)(4).This report refers to investigation related to auto logic pump with serial number (b)(4), with the following results.Evaluation of the device in question (serial number (b)(4)) revealed that an power cord insulation was cut.Based on the photo attached to the complaint record, there were signs of burning marks on the power cable.No incident related to this pump was reported to arjo.Circumstances in which the power cord was damaged are unknown.According to the instruction for use (630900en), 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for use mains cable should be carefully inspected.When any malfunction is noticed, the device should be immediately withdrawn from the use until the service is performed.The complaint was assessed as reportable one in abundance of caution due to signs of burning marks on the power cable.The power cord was found to be damaged and from that perspective, the device did not meet performance specification.No injury or other medical consequences were reported.It is unknown if the power cord was damaged when the device was in use by a patient.

Event Description

Following a visit at the customer site related to a complaint recorded under arjo internal number (b)(4) (medwatch#3005619970-2020-00009), a former arjo technician collected auto logic pump with serial number (b)(4).Evaluation of the device in question (serial number (b)(4)) revealed that an power cord insulation was cut.Based on the photo, there were signs of burning marks on the power cable.No incident related to this pump was reported to arjo.Circumstances in which the power cord was damaged are unknown.

• 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: 10776531
• MDR Text Key: 257114460
• Report Number: 3005619970-2020-00019
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: DK
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 630004DK
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2013
• 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