MAUDE Adverse Event Report: PHILIPS INDIA LTD. BV PULSERA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BV PULSERA
Medical Device Problem Codes	Positioning Failure (1158); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported to philips that the radiographer got finger injury while using the locks on the c-arm.Intervention is unknown.Philips has started an investigation of the complaint.
Additional Manufacturer Narrative
Philips has conducted an investigation into this complaint.The radiographer sustained an injury to the right index finger when unlocking the brakes and rotating the bv pulsera system.The distal end of the finger was bleeding and bruised.To treat the injury ice and a bandage were applied which did not impact the radiographer's ability to continue working.This incident is being treated as a product problem.A philips field service engineer (fse) inspected the system onsite and identified that the cause of the issue was that the system was over rotated 360 degrees, causing the c-arc cable to get coiled over the angulation brake.When the device was further rotated by the user, the angulation brake was inadvertently released by the cable, pinching the right index finger, which was placed underneath the brake lever.The instructions for use describe that the range of rotation of the bv pulsera is from -180 to +180 degrees with a safety stop at -135 and +135 degrees.In this case the c-arc was moved beyond the 180 degrees causing the c-arc cable to become entangled.The investigation has concluded that there was no malfunction of the philips system.The codes were updated based on the investigation outcome.Device problem code and health impact code were corrected.

• Brand Name: BV PULSERA
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS INDIA LTD.; plot no. b-79, midc,; phase-ii, chakan; pune 41050 1; IN 410501
• Manufacturer (Section G): PHILIPS INDIA LTD.; plot no. b-79, midc,; phase-ii, chakan; pune 41050 1; IN 410501
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16068697
• Report Number: 3003768277-2022-01854
• Device Sequence Number: 17700764
• Product Code: OWB
• UDI-Device Identifier: 00884838055506
• UDI-Public: 00884838055506
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010435
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BV PULSERA
• Device Catalogue Number: 718095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown