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 Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

A customer reported to arjo that an auto logic pump did not work and emitted strange smell.The issue occurred at time of use the auto logic system by a patient.No injury was reported.An inspection of the rental pump conducted by an arjo technician revealed that a pump power cord was mechanically damaged.Sign of burning mark was observed on the broken insulation.The destruction occurred when the cable was pinched between a bed frame and a side rail.The pump was installed by the customer's staff without use of the cable management system.According to the instruction for use ((b)(4)), 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 sign of burning mark on the power cord cable with damaged insulation.

Event Description

A customer reported to arjo that an auto logic pump did not work and emitted strange smell.The issue occurred at time of use the auto logic system by a patient.No injury was reported.An inspection of the rental pump conducted by an arjo technician revealed that a pump power cord was mechanically damaged.Sign of burning mark was observed on the broken 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 12574492
• MDR Text Key: 274751315
• Report Number: 3005619970-2021-00018
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784252
• UDI-Public: (01)05055982784252(11)170220
• 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,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2017
• 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