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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Arjo was informed by a customer about an event involving an arjo auto logic pump.Following information reported, a power cable was damaged by a bed¿s side rail causing a short circuit of the pump, and blacking out several rooms at the customer facility.No injury nor other medical consequences were reported to arjo.During an inspection of the involved device performed by arjo representative, it was found that the main power cable was physically damaged and burnt.The pump was installed on the bed by the customer's staff without use of the cable management system.The damaged occurred when the cable was trapped in the bed¿s side rail mechanism.According to instruction for use (630933en), the user shall ¿make sure that the power cables (¿) 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the mains cable should be carefully inspected.When any malfunction is noticed, the device should be immediately withdrawn from the use until the service is performed.The complaint was decided to be reportable due to malfunction of the power cord, which resulted in the short circuit of the pump, and blacking out several rooms at the customer facility.The power cord was found to be damaged, and from that perspective, the device did not meet performance specification.The device was in use by the patient when the malfunction occurred.No injury or other medical consequences were reported.

Event Description

Arjo was informed by a customer about an event involving an arjo auto logic pump.Following information reported, a power cable was damaged by a bed¿s side rail causing a short circuit of the pump, and blacking out several rooms at the customer facility.No injury nor other medical consequences were reported 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: 10526970
• MDR Text Key: 206759256
• Report Number: 3005619970-2020-00018
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784252
• UDI-Public: (01)05055982784252(11)171023
• 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: Other
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 630009AU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2017
• 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