MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 8000X WITH INDIGO; 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 02/01/2021

Event Type  Injury  

Manufacturer Narrative

The process of gathering information is ongoing.The results of the analysis will be provided to the follow-up report.

Event Description

Arjo was informed about 5 defective power supply cables for the indigo module (intuitive drive assist).Sparks and and black marks were visible.No injury was reported.(medwatch reports numbers 3007420694-2021-00016; 3007420694-2021-00017; 3007420694-2021-00019; 3007420694-2021-00020).

Manufacturer Narrative

The evaluation of the bed performed by arjo technician confirmed the problem of the damaged power supply cable.The results of the analysis will be provided upon conclusions of the investigation.

Manufacturer Narrative

The claimed beds were inspected and repaired internally by the facility staff.The indigo power supply cables were replaced and after functionality testing, beds were released for use.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 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for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from the user until the service is performed.To sum up, the complaint was decided to be reportable due to the power supply cable malfunction resulted in sparks.This component was found to be damaged and from that perspective, the device did not meet performance specifications.There was no indicatin regarding patient involvement when the malfunction was observed.H3 other text : internally by facility.

• Brand Name: ENTERPRISE 8000X WITH INDIGO
• 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: 11327097
• MDR Text Key: 232519638
• Report Number: 3007420694-2021-00018
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056341602354
• UDI-Public: (01)05056341602354(11)190924
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8X33V41CON6450
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other