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

Model Number	BV PULSERA
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported to philips that during a procedure in (b)(6) 2024, the c-arm was being rotated in the oblique direction by the user during a surgery.They stated that the c-arm was more difficult than usual to push.They bent down to use their legs and felt a pull in their right-side flank and into the lower back.The user was advised to take ibuprofen and rest.The user reported that in (b)(6) 2024 they reinjured their back in the same way.They were advised by two different nurse practitioners to rest and use the medications provided along with ice and heat.It was recommended to have the injury further evaluated by a physician.The user is currently unable to work and waiting for physical therapy, an mri, and x-rays to be approved.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
Philips has investigated this complaint.According to the additional information received, it was confirmed that the customer site operates two bv pulsera systems and that a similar movement issue has been reported for both systems.On june 12, 2025, during an onsite visit, the field service engineer (fse) reviewed the details with the customer and verified that the user injury was linked to the other bv pulsera system, not the one originally identified.For the system covered in this complaint, it was confirmed that there was no user harm and no reported impact on the patient or the clinical procedure.The reported issue for this system was difficulty with in and out c arm movement.The fse went onsite and confirmed the reported issue.To resolve the issue, the field service engineer (fse) replaced the bearingblock assy ext rot, and the removed part was returned for further analysis.Analysis of the returned part identified a loose and or broken internal component.After replacement, functional checks, including movement verification, confirmed that the system was operating within specification and the system was returned ready for clinical use.Through the additional investigation, philips identified that planned maintenance (pm) instructions did not include inspection and cleaning steps for the extended rotation mechanism.Philips will assess whether the instructions should be further clarified and will take appropriate action if deemed necessary.At the time this complaint was received, philips did not have sufficient information to rule out the possibility of a serious injury related to the reported system issue.Therefore, the complaint was initially reported.Following a thorough investigation, philips confirmed that no user harm occurred for this system.As such, this complaint has been re-evaluated as not reportable.The investigation concerning the reported user injury is documented separately under mfr report number 3003768277-2026-100579.The codes were updated based on the investigation outcome.
Additional Manufacturer Narrative
Philips received additional information confirming that no issue was reported by the customer regarding the present system.However, at the time of reporting, the complaint was incorrectly logged under the present system for an event reported to have occurred on (b)(6) 2024.During the onsite visit related to the present system, no replacement of the extended rotation bearing block assembly (bearingblock assy ext rot) was performed.The field service engineer (fse) observed increased resistance during the in-and-out movement of the c-arm.Visual inspection of the bearing block assembly identified dust accumulation and rust on the bearings behind the velcro covers, and some bearings did not rotate consistently along the rail.A force measurement of 74 n was recorded compared with the 70 n reference value.The fse cleaned, vacuumed, and sprayed silicone lubricant into the c-arm channel and bearings were performed and applied teflon to the bearing box.After functional checks, the system was tested and returned to use in good working order.The fda establishment registration number [fei] has been updated and reported to the fda, changing from 3003768277 to 3042175844, effective december 21, 2025.This change reflects as administrative registration update only.There have been no changes to the registered owner/operator, official correspondent, legal entity name, physical establishment address, manufacturing processes, or to the design, specifications, intended use, or manufacturing processes of any listed devices.

• 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: derrick massuri ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 20460105
• Report Number: 3003768277-2024-05862
• Device Sequence Number: 7794298
• Product Code: OWB
• UDI-Device Identifier: 00884838055506
• UDI-Public: 00884838055506
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 03/05/2026

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: 09/19/2024
• Supplement Date Received by Manufacturer: 01/28/2026; 03/05/2026
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 02/05/2026; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2010
• 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