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
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported an orthoscan mini c-arm unit spontaneously engaged in fluoroscopy mode.The orthoscan mini c-arm unit was parked in a corner of an occupied operating room (or) suite, plugged in to wall power, and turned on, with the foot pedal mounted on the side of the unit.The or staff heard a five-minute alarm sound, indicating that the fluoroscopy unit had been emitting ionizing radiation for five minutes.The or staff then contacted radiology staff to turn unit off.Personnel and patients may have been exposed to unnecessary radiation.An orthoscan service engineer arrived at the facility to investigate/repair alleged malfunctioning unit where it was found the sheath/covering of the umbilical cable had a tear - causing a short and allowing the unit to engage in fluoroscopy mode.A new umbilical cable assembly was installed which corrected the malfunction.The service engineer 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.

• 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: 8675781
• Report Number: 3005254598-2019-70003
• Device Sequence Number: 2358972
• 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): 05/09/2019

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?: Yes
• 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