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

Model Number E5X3FL003BEBOA

Device Problems Smoking (1585); Electrical Shorting (2926)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

During a service visit to another device, an arjo service technician was informed that smoke and a burning smell were observed near the enterprise 5000x bed.It was indicated that a short circuit had occurred when the enterprise 5000x bed's backrest was lowered using the handset.No patient was on the bed and no hospital employees were injured.The service technician diagnosed that a short circuit in the power socket on the wall caused damage to the power cable (burn marks) of the bed and the control box.The arjo service technician noticed a small broken metal piece in the wall socket and informed the hospital department of the issue.

Manufacturer Narrative

The process of analyzing the information is ongoing.Additional information will be provided upon completion of the investigation.

Manufacturer Narrative

During a service visit to another device, an arjo service technician was informed that smoke and a burning smell were observed near the enterprise 5000x bed.It was indicated that a short circuit had occurred when the enterprise 5000x bed's backrest was lowered using the handset.No patient was on the bed and no hospital employees were injured.The service technician diagnosed that a short circuit in the power socket on the wall caused damage to the power cable (burn marks) of the bed and the control box.The arjo service technician noticed a small broken metal piece in the wall socket and informed the hospital department of the issue.Photographic evidence received and information provided (incl.Inspection results) indicate that the short circuit that occurred and caused the damages to power cable (burnt marks) and the control box might be a result of a small broken metal piece found in the wall socket.Arjo device failed to meet its performance since the power cable and the control box became damaged.No patient was in the bed at the time of the event.This complaint was deemed reportable due to a short circuit in an electrical socket on the wall, which caused damage to the power cord ('burn marks').No injuries were sustained.

• 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: 18363369
• MDR Text Key: 330981886
• Report Number: 3007420694-2023-00302
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05059441177531
• UDI-Public: (01)05059441177531(11)210803
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: E5X3FL003BEBOA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2021
• 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