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

Model Number 8X33V41CON6450

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

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

Event Date 12/03/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

Event Description

Following the information provided the patient was placed on the bed when a loud bang was heard and power went out in the ward.The hospital technical staff found tha the bed was causing a power trip.The customer's technical staff inspected the bed and noticed that the indigo module (intuitive drive assist) power supply cable had burned out.No injury was sustained.The evaluation performed by arjo service technicians revealed that the power supply cable became damaged at the bending point and caused a short circuit.Black marks were visible on the cord.The part was replaced and reinstalled in accordance to the instructions.The correct functionality was confirmed after the repair.

Manufacturer Narrative

The investigation is pending.The conclusions will be provided within the follow-up report once the investigation is completed.

Manufacturer Narrative

The investigation performed by the manufacturer revealed that the damage was caused by the inner wire deterioration due to stress applied during up and down movements of the bed.The instructions for use for enterprise 8000x (746-585-en rev.13) include the following warnings: "disconnect the bed from the electricity supply before starting any cleaning and maintenance activity." "do not allow the mains plug or power supply cord to get wet." as per the preventive maintenance section of the instructions for use for indigo (416260-en rev.C), 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for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed and arjo employee should be notified.Arjo device failed to meet its performance specification since the power supply cable was damaged.The device was used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to burning 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13025079
• MDR Text Key: 282724846
• Report Number: 3007420694-2021-00170
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056341602354
• UDI-Public: (01)05056341602354(11)200409
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8X33V41CON6450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2020
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 75 KG