MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 8000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 8X23GL103BCAHA

Device Problem Circuit Failure (1089)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Event Description

The arjo technician detected a malfunction of the indigo power supply cable that was already repaired by the customer staff.The cable had broken insulation and signs of burning marks.The enterprise 8000x bed was not in use at that time.No injury was reported.

Manufacturer Narrative

During conducting of the field action (z-2588-2021, fsn-poz-001-2021) on the enterprise 8000x bed, the arjo technician detected a malfunction of the indigo power supply cable that was already repaired by the customer staff.The cable had broken insulation and signs of burning marks.No patient was involved at that time.No injury was reported.Based on the photographic evidence provided, one of the internal wires was broken causing a short circuit.The part was replaced and reinstalled in accordance with the instructions by the arjo technician.An investigation performed by the manufacturer revealed that 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for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed.The analyzed issue (power supply cable failure) was addressed by field safety corrective action z-2588-2021 (fsn-poz-001-2021) that has been already completed on the us market.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 was detected.No injury was sustained.The complaint was assessed as reportable due to signs of burn marks on the power supply cable of indigo module (intuitive drive assist).

• Brand Name: ENTERPRISE 8000X
• 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: 16609830
• MDR Text Key: 312241576
• Report Number: 3007420694-2023-00060
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05059441129967
• UDI-Public: (01)05059441129967(11)210203
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8X23GL103BCAHA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2588-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other