MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number	ALLURA XPER FD10
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that during a planned treatment procedure the wireless footswitch did not work properly and the wifi indicator was red.The procedure was completed using the wired footswitch.No harm to the patient has been reported to philips.
Additional Manufacturer Narrative
The philips engineer reset the wireless footswitch by disconnecting and reconnecting the battery.Philips has confirmed that the reported failure is due to a connectivity issue.Due to a firmware bug the wireless foot switch can suddenly stop responding when a number of ambient conditions coexist, such as emc disturbance and the presence of other wireless devices in the room.Philips has initiated a medical device correction/field safety corrective action (2021-igt-bst-020).Philips has attempted to obtain patient information.The customer declined to provide patient details.No patient information could be obtained.

• Brand Name: ALLURA XPER FD10
• Common Device Name: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12842746
• Report Number: 3003768277-2021-10233
• Device Sequence Number: 4352952
• Product Code: IZI
• UDI-Device Identifier: 00884838059191
• UDI-Public: 00884838059191
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K041949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial

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: ALLURA XPER FD10
• Device Catalogue Number: 722003
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown