MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 5000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number E5X3DL10CON2632

Device Problem Sparking (2595)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

Following the information provided the nurse had brought down bed from level 4 corridor.The bed was plugged into power outlet in cubicle 21 and at this point there was a spark and a smell of burning.When arjo technician checked the coiled mains cable he found it to be damaged and suspected that it shorted against bed frame.As per the information provided by arjo technician the facility staff has a habit of wrapping the power cord around the bed frames, which leads to stretching and damages to power cord when the bed is raised with the cable wrapped.The technician suspects that the coiled mains cable has been wrapped around the bed frame previously and then the bed was raised thus causing damage to the cable.The photographic evidence provided confirms this hypothesis.There is no indication of patient involvement.No injury was sustained.The bed was repaired by replacing the power cord.

Manufacturer Narrative

Based on the collected information the root cause of the complained scenario is considered use error.The photographic evidence and information provided indicate that the power cord damage was a result of wrapping the cord between the base frame and the headboard, which resulted in overstretching and damage of the power cord, when the bed was raised, subsequently causing sparks when the bed with damaged cord was plugged into the mains outlet.The instructions for use for the enterprise 5000x bed (746-577-en) include the following information related to the cable damages and regular inspections: "make sure the power supply cord is not stretched, kinked or crushed." "make sure the power supply cord does not become entangled with moving parts of the bed." "visually check power supply cord and mains plug" - this activity is to be done by the caregiver weekly."examine the power supply cord and mains plug - if damaged, replace the complete assembly; do not use a rewireable plug" - this activity is to be done by the qualified personnel during yearly preventive maintenance procedures.Arjo device failed to meet its performance specification since the power cord was damaged and sparked after plugging it to the power outlet.There is no indication of patient involvement at the time of event.This complaint is deemed reportable due to allegation of power cord damage resulting in sparking and burnt smell.

• Brand Name: ENTERPRISE 5000X
• 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: 15893294
• MDR Text Key: 307999014
• Report Number: 3007420694-2022-00199
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: E5X3DL10CON2632
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2014
• 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