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

Model Number E5G3QY103BFAZA

Device Problems Circuit Failure (1089); Sparking (2595)

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

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the device performed by an arjo representative revealed that the indigo power supply cable became damaged at the bending point.The burning marks were visible on the cable insultaion.The damage of the indigo power supply cable was a result of the inner wire deterioration due to stress applied during up and down movements of the bed.As per the preventive maintenance section of the instructions for use for indigo (416260) the indigo cables should be examined for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed.Sum up, the cause of the reported power supply cable failure was determined as inner wire deterioration due to stress applied during the movement of the bed platform.Arjo device failed to meet its specification since the power supply cable was damaged.The device was not used for a patient treatment when the failure occurred.The complaint was decided to be reportable due to the power supply cable damage (insulation damage leading to sparks emission and visible black marks).The analyzed issue (power supply cable failure) was addressed by field safety corrective action z-2588-2021 (fsn-poz-001-2021).

Event Description

Arjo received a customer complaint related to an enterprise 5000x bed equipped with an indigo module (intuitive drive assist).The customer staff reported a spark coming from the indigo power supply cable.The bed was not in use by a patient at that time.No injury was reported.

• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 18844895
• MDR Text Key: 337761413
• Report Number: 3007420694-2024-00067
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05059441138686
• UDI-Public: (01)05059441138686(11)200910
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: E5G3QY103BFAZA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FSN-POZ-001-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other