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

Model Number 8X33VQ113DFDSA

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

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

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided upon conclusions of the investigation.

Event Description

Arjo was informed by the end user that sparks were coming from the indigo power supply cable.There was no patient involved and no injury was reported.The inspection of the bed performed by the arjo representative revealed that the power supply cable was damaged- broken isolation with black marks visible.

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.Corrective and preventive action (capa) has been commenced to address the issue and prevent it from reoccurring.Actions taken in the course of the capa ensure that newly manufactured devices will be free of the recognized failure mode and the affected devices will be corrected effectively.On 19 may 2021, the field safety corrective action (fsca, internal number (b)(4), submitted to fda under no.3007420694-05/24/21-001-c) has been commenced to all arjo customers owning the bed equipped with indigo module.The instructions for use for the enterprise 8000x (746-585) 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), 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for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed.To sum up, the complaint was decided to be reportable due to the indigo power supply cable malfunction resulted in sparks.This component was found to be defective and from that perspective, the device did not meet performance specifications.There was no patient involved when the malfunction was observed.

• 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
• MDR Report Key: 11893052
• MDR Text Key: 253813391
• Report Number: 3007420694-2021-00079
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097352077
• UDI-Public: (01)05056097352077(11)200922
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8X33VQ113DFDSA
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other