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 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation performed by the manufacturer revealed that the damage of power supply cable is a result of 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.(b)(4)) has been commenced to all arjo customers owning the bed equipped with indigo module.The device was repaired by an arjo technician.The indigo power supply cable was replaced and cable routing was corrected.No product problem occurred after the repair.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for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed.To sum up, the complaint was decided to be reportable due to the indigo power supply cable malfunction resulted in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 and black marks.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.

Event Description

Following information gathered, the short circuit of the power supply cable for the indigo module (intuitive drive assist) occurred resulting in noticeable sparks.The insulation was broken with black marks visible.There was no indication regarding patient involvement.No injury was reported.

• 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 12265554
• MDR Text Key: 264843269
• Report Number: 3007420694-2021-00108
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056341602354
• UDI-Public: (01)05056341602354(11)190918
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8X33V41CON6450
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• 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