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

Model Number 630EUR

Device Problem Sparking (2595)

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

Event Date 11/05/2021

Event Type  malfunction  

Event Description

It was reported that when a nurse was trying to connect an auto logic pump to the main socket, she observed bang, sparks and smoke.The pump was removed from use.No injury occurred.

Manufacturer Narrative

It was reported that when a nurse was trying to connect an auto logic pump to the main socket, she observed bang, sparks and smoke.The pump was removed from use.No injury occurred.An arjo technician during an on-site visit checked the device and found the pump power cord was mechanically damaged.The insulation was broken exposing the internal copper wires.It contributed to occurring the sparks and smoke.Based on the photo of the cable, it seems the most probable that the cable was pinched in moving bed mechanism.According to the instruction for use (630933en), arjo recommends to ¿make sure that the mains power cable (.) 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 power cord was found to be damaged and from that perspective, the device did not meet performance specification.The device was used by the patient.No injury or other medical consequences occurred.The complaint was assessed as reportable due to indication about occurring the sparks from the power cord cable with damaged insulation.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 12859554
• MDR Text Key: 285497998
• Report Number: 3005619970-2021-00022
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784283
• UDI-Public: (01)05055982784283(11)170706
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2017
• 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
• Patient Age: 93 YR
• Patient Sex: Male
• Patient Weight: 82 KG