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 09/01/2021

Event Type  Injury  

Manufacturer Narrative

The end-user reported that the loud noise and sparks were observed from the enterprise 9000x bed equipped with an indigo module (intuitive drive assist).The issue occurred at time of use the bed by a patient.No injury was reported.The evaluation of the device performed by an arjo representative revealed that there was a small burn mark on the indigo power supply cable.After opening the insulation, it was found that the internal wires were broken.The indigo power supply cable was replaced, the cable routing was corrected and the bed's proper functionality was confirmed during testing.An investigation performed by the manufacturer revealed that the damage of the power supply cable was a result of the inner wire deterioration due to stress applied during up and down movements of the bed.The instructions for use for the enterprise 9000x (746-591) 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for cuts, abrasions, kinks or other deterioration.When any malfunction is noticed, the device should be immediately withdrawn from use until the service is performed.To sum up, the complaint was decided to be reportable due to the indigo power supply cable malfunction resulted in sparks and black mark.This component was found to be defective and from that perspective, the device did not meet performance specifications.The bed was in use when the malfunction was observed.

Event Description

The end-user reported that the loud noise and sparks were observed from the enterprise 9000x bed equipped with an indigo module (intuitive drive assist).The issue occurred at time of use the bed by a patient.No injury was reported.

• 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 12479400
• MDR Text Key: 271693783
• Report Number: 3007420694-2021-00122
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05056351698104
• UDI-Public: (01)05056351698104(11)200903
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9625A2101BAATD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• 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
• Patient Age: 55 YR
• Patient Weight: 102