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

Model Number	1000-0004-FD
Medical Device Problem Code	Unexpected/Unintended Radiation Output (4028)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: MINI C-ARM PULSE
• Manufacturer (Section D): ORTHOSCAN; 14555 n 82nd street; scottsdale 85260
• MDR Report Key: 8675779
• Report Number: 3005254598-2019-70004
• Device Sequence Number: 18915984
• Product Code: OXO
• UDI-Device Identifier: B22510000004FD0
• UDI-Public: B22510000004FD0
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 1000-0004-FD
• Device Catalogue Number: 1000-0004-FD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1