MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ENTERPRISE 9000X; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 9625A2101BAATD

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

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

Following the information provided, the customer reported that the bed was causing a power trip.The evaluation of the bed revealed that the indigo (intuitive drive assist) module power supply cable insulation was cut, the internal wires were broken, emitting sparks.No patient was involved at the time of event.No injury was sustained.The arjo engineer replaced the power cable and corrected the cable routing.The appropriate bed functionality was confirmed through functional testing.

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 9000x ( (b)(4)) 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 ( (b)(4)), 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for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed and arjo employee should be notified.Arjo device failed to meet its performance specification since the power supply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.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 damaged leading to spark emission and visible black marks).

• Brand Name: ENTERPRISE 9000X
• 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: 12959989
• MDR Text Key: 281908735
• Report Number: 3007420694-2021-00162
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056341698104
• UDI-Public: (01)05056341698104(11)200904
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9625A2101BAATD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2020
• 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