MAUDE Adverse Event Report: LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE; IXR

Model Number 404007

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2015

Event Type  malfunction  

Event Description

Customer reports via phone that during an undetermined urology procedure, the system monitors failed and the fluoro image could not be seen.Staff moved two mobile monitors into the room and the procedure was completed without further incident.Customer provided no further procedural or patient information, other than to say the patient is fine.No reported injury.

Manufacturer Narrative

Service tech advised that since both monitors appeared to not work to check the monitor power supply.Biomed measured the power supply output to the monitors and found the output was 10 volts dc instead of the required 12 volts dc.Tech service gave the biomed the part number needed for a replacement power supply and transferred him to parts for ordering.Mallinckrodt product monitoring follow up; (b)(6) 2015, biomed reports they had replaced the monitor power supply and the system is fully functional.Facility biomed completed repairs.

• Brand Name: HUT EXT DR FINAL ASSY-REVERSE
• Type of Device: IXR
• Manufacturer (Section D): LIEBEL FLARSHEIM; 2111 east galbraith road; cincinnati OH 45237
• Manufacturer Contact: david benson ; 2111 east galbraith road; cincinnati, OH 45237 ; 5139485719
• MDR Report Key: 4726396
• MDR Text Key: 18785113
• Report Number: 1518293-2015-00026
• Device Sequence Number: 1
• Product Code: IXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/26/2015

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: Health Professional
• Device Model Number: 404007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2007
• 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