MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 5000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number E5X1N41CON10023

Device Problem Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

Process of analyzing information is ongoing.Additional information will be provided upon conclusion of the investigation.

Event Description

Arjo has been notified of an incident involving the enterprise 5000x bed.Burning marks were found on the power socket and plug.No patient was on the bed at the time of the event.No injuries were reported.It was indicated that a fuse had tripped.The light was off, which prompted the customer to check why the power was off.It turned out that the socket and plug were burned out.Before calling arjo, the facility's in-house electrician replaced the socket with a new one and reconnected the plug to the bed, which immediately burned out.The device was inspeced by an arjo representative.The plug and the socket were found with burnt marks.The following parts were replaced: the power cord, the control box and the battery box.After replacing the parts, the bed worked without any issues.

Manufacturer Narrative

Arjo was notified of an incident involving the enterprise 5000x bed.Burning marks were found on the power socket (part of the customer's electrical installation) and the bed power cord plug.No patient was in the bed at the time of the event.No injuries were reported.It was indicated that fuse which is part of the customer's electrical installation was tripped.The light was off, which prompted the customer to check why the power was off.It turned out that the power socket and the bed power cord plug were burned out.Before calling arjo, the facility's in-house electrician replaced the power socket with a new one and reconnected the bed power cord plug, which immediately burned out.However, the installation fuse did not trip right away.The device was inspected by an arjo representative.There were no cuts or damaged found with main cable of the bed.There was no short circuit on the control box between any of the working pins and the ground pin.The power cord, the control box and the battery box were replaced.No issues was found after parts replacement.It was also indicated that the power plug sometimes was not plugged in fully.Photographic evidence received, information provided and consultation with the manufacturer indicate that the burnt marks on the plug and socket might be a result of a faulty customer's electrical installation to which the bed was connected.The bed's main cable was in good condition, and the fuse did not trip right away when the socket was replaced.Arjo device failed to meet its performance since the power plug of the bed was damaged.No patient was in the bed at the time of the event.This complaint is deemed reportable due to allegation of burning marks found on the power socket plug.

• Brand Name: ENTERPRISE 5000X
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18027822
• MDR Text Key: 326800675
• Report Number: 3007420694-2023-00260
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05059441312826
• UDI-Public: (01)05059441312826(11)230703
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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,Followup
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: E5X1N41CON10023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2023
• 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