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

Model Number 630009AU

Device Problems Electrical /Electronic Property Problem (1198); Sparking (2595)

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

Event Date 11/30/2020

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).An inspection of the involved device was performed by an arjo representative.It was confirmed that the main power cable was physically damaged, copper wires were exposed.The destruction occurred when the cable was squeezed (jam) in the bed¿s mechanism.An investigation is ongoing, the conclusions will be provided in the final report.

Event Description

Arjo was informed by a customer representative about an issue involving an arjo auto logic pump.Following information reported, a main power cable was physically damaged (pinched), and burnt.It allegedly caused a power issue (blackout) on one of hospital wards.No injury, nor other medical consequences were reported to arjo.

Manufacturer Narrative

Arjo was informed by a customer representative about an issue involving an arjo auto logic pump.The pump 'blew up¿ what allegedly caused a power issue (blackout) on one of hospital wards therefore an arjo service was requested by a facility staff.No injury nor other medical consequences were reported to arjo.During a device inspection performed by an arjo technician, it was found that the main power cable was physically damaged (copper wires were exposed).The destruction occurred when the cable was squeezed (jam) in the bed¿s mechanism.At that time, the short circuit /sparks (named by the customer as 'blew up¿) could be observed by the customer.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.Where cable management flaps are provided along the sides of the mattress, these should be used to cover the mains power cable.¿ 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for use mains cable should be carefully inspected.When any malfunction is noticed, the device should be immediately withdrawn from the use until the service is performed.The complaint was assessed as reportable in an abundance of caution due to issue related to power cord (¿blew up¿) which occurred at the time of the device use by a patient.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 occurred.

• 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: 11034859
• MDR Text Key: 223165723
• Report Number: 3005619970-2020-00023
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• 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: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other