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

Model Number 630004NL

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 10/30/2023

Event Type  malfunction  

Event Description

Arjo became aware of the event involving the auto logic pump.When the caregiver was lowering the bed, the pump¿s power cable trapped between the bed¿s moving parts.It caused a short circuit and blowing of the fuse from facility¿s electrical system.While putting the fuse back in, the caregiver noticed the damaged power cable with exposed wires and unplugged the pump.At that time spark was created and the caregiver received electric shock.The caregiver reported that plugged the pump into the socket located higher on the wall to prevent the cord from being trapped again and used the pump with damaged power cable.The pump was in use by the patient when the event occurred.No patient¿s injury was reported.

Manufacturer Narrative

The provided photographic evidence confirmed that the mains power insulation was damaged and wires were exposed.The photographic evidence provided also showed that the cable was not positioned in the mattress cable management system.According to the auto logic instruction for use (630933en_09), 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.¿ to conclude, upon the conducted investigation, it was determined that the cable management system was not used.It caused that the power cord was damaged when it was trapped between moving parts of the bed.The damage of the power cable was a contributing factor to the electric shock occurrence.When the event occurred, the device did not meet its performance specifications (cable was damaged).The pump was in use by the patient at that time.The device played a role during this event as it caused an electric shock.The complaint was decided to be reportable due to the allegation of the electric shock received by the caregiver.No patient injury was claimed.

• 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: 18129830
• MDR Text Key: 328026979
• Report Number: 3005619970-2023-00028
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 05055982784283
• UDI-Public: (01)05055982784283(11)191218
• 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: Other
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 630004NL
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2019
• 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 Sex: Male