MAUDE Adverse Event Report: ORTHOSCAN ORTHOSCAN MINI C-ARM PULSE

Model Number 1000-0004-FD

Device Problem Unexpected/Unintended Radiation Output (4028)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

Event Type  malfunction  

Event Description

It was reported that during a procedure, an orthoscan mini c-arm was setup in the procedure room and before use, it alarmed where it was discovered it had spontaneously given off fluoroscope / x-ray for a duration of 5 minutes.Personnel and patient(s) may have been exposed to unnecessary radiation.It determined the facility staff had been using the umbilical cable assembly as a handle when maneuvering system and/or adjusting c-arm position.As a result of the excessive pulling on the umbilical cord, the insulating properties of the cable were damaged.No further event nor patient information was received.

• Brand Name: ORTHOSCAN MINI C-ARM PULSE
• Type of Device: MINI C-ARM PULSE
• Manufacturer (Section D): ORTHOSCAN; 14555 n 82nd street; scottsdale 85260
• Manufacturer (Section G): ORTHOSCAN; 14555 n 82nd street; scottsdale 85260
• Manufacturer Contact: steve seeman ; 14555 n 82nd street; scottsdale 85260 ; 4805038010
• MDR Report Key: 8675779
• MDR Text Key: 150572637
• Report Number: 3005254598-2019-70004
• Device Sequence Number: 1
• Product Code: OXO
• UDI-Device Identifier: B22510000004FD0
• UDI-Public: B22510000004FD0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2019

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: 1000-0004-FD
• Device Catalogue Number: 1000-0004-FD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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