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

Model Number E5X2H4113DBAFB

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

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

Event Date 10/25/2021

Event Type  malfunction  

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.The instructions for use for the enterprise 5000x (746-577-en rev.16) 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-en rev.C), 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for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed and arjo employee should be notified.Arjo device failed to meet its performance specification since the power supply cable was damaged.There is no indication that device was used for a patient treatment when the failure occurred.The complaint was decided to be reportable due to the power supply cable malfunction (internal wires breakage and scorched marks visible).

Event Description

Following the information provided the power supply cable of indigo module (intuitive drive assist) was damaged.There is no indication of patient involvement at the time of the event.No injury was sustained.The evaluation of the device revealed that the cable insulation was damaged at the bending point.There were visible scorched marks on the cable.The arjo engineer replaced the power cord and confirmed correct bed functionality.

• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 12843653
• MDR Text Key: 282282734
• Report Number: 3007420694-2021-00151
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056097315607
• UDI-Public: (01)05056097315607(11)200803
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: E5X2H4113DBAFB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2020
• 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