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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 8000X; BED, AC-POWERED ADJUSTABLE HOSPITAL
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ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 8000X; BED, AC-POWERED ADJUSTABLE HOSPITAL Back to Search Results
Model Number 8X23GL103BCAHA
Device Problems Circuit Failure (1089); Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2023
Event Type  malfunction  
Event Description
Arjo has received a customer complaint related to an enterprise 8000x equipped with an indigo module (intuitive drive assist).The customer staff reported a spark and smoke coming from the indigo power supply cable.There was no allegation that the bed was in use at that time.No injury was reported.
 
Manufacturer Narrative
The evaluation of the device performed by an arjo representative revealed that the indigo power supply cable became damaged at the bending point.On the insulation of the cable were observed burning marks.The investigation is ongoing.Results of the analysis will be provided to the follow-up report.
 
Manufacturer Narrative
Arjo has received a customer complaint related to an enterprise 8000x equipped with an indigo module (intuitive drive assist).The customer staff reported a spark and smoke coming from the indigo power supply cable.There was no allegation that the bed was in use at that time.No injury was reported.The evaluation of the device performed by an arjo representative revealed that the indigo power supply cable became damaged at the bending point.The burning marks were visible on the cable insultaion.The part was replaced and reinstalled in accordance to the instructions.An investigation performed by the manufacturer revealed that the damage of the indigo power supply cable was a result of the inner wire deterioration due to stress applied during up and down movements of the bed.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for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed.The analyzed issue (power supply cable failure) was addressed by field safety corrective action z-2588-2021 (fsn-poz-001-2021) that has been already completed on the us market.Sum up, the cause of the reported power supply cable failure was determined as inner wire deterioration due to stress applied during the movement of the bed platform.Arjo device failed to meet its specification since the power supply cable was damaged.The device was not used for a patient treatment when the failure occurred.The complaint was decided to be reportable due to the power supply cable damage (insulation damage leading to sparks emission and visible black marks).
 
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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
justyna kielbowska
ks. wawrzyniaka 2
komorniki 62-05-2
PL   62-052
883337089
MDR Report Key16544118
MDR Text Key311485884
Report Number3007420694-2023-00053
Device Sequence Number1
Product Code FNL
UDI-Device Identifier05059441129967
UDI-Public(01)05059441129967(11)210203
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Administrator/Supervisor
Remedial Action Repair
Type of Report Initial,Followup
Report Date 04/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8X23GL103BCAHA
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-2588-2021
Patient Sequence Number1
Patient Outcome(s) Other;
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