MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BV PULSERA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	BV PULSERA
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); Skin Tears (2516)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the user lowered the table of a bv pulsera system without the c-arm being fully removed from underneath the table.This caused the c-arm to be bumped and tip over.As a result, the technologist¿s left ankle was reported to be degloved and require 22 stiches to repair the skin.Stiches were removed after approximately one week and there was no lasting effect or impact to the technologist¿s health.Furthermore, it was confirmed that there was no impact to the patient.The procedure had already been completed when the incident occurred and hospital staff were taking the patient off of the table.A philips field service engineer (fse) inspected the system onsite and repaired the steering system that slid due to the c-arm physically tipping over.The system was returned to use in good working order.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information acquired, the user lowered a non-philips operating theater table without the mobile philips bv pulsera c-arm being fully removed from underneath the table.This resulted in the philips mobile system tipping over.The philips mobile system and the non-philips table movements are independent and isolated from each other.Based on the results of the investigation, philips has concluded that the philips mobile system was working as intended and that this event as not reportable.The codes were updated based on the investigation outcome.(device) problem code grid, patient outcome code grid & health impact grid code was corrected.

• Brand Name: BV PULSERA
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17459815
• Report Number: 3003768277-2023-04299
• Device Sequence Number: 7106017
• Product Code: OWB
• UDI-Device Identifier: 00884838055506
• UDI-Public: 00884838055506
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown