MAUDE Adverse Event Report: PHILIPS HEALTHCARE BV LIBRA, MOBILE X-RAY UNIT; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number 718022

Device Problem Complete Blockage (1094)

Patient Problem Electric Shock (2554)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.

Event Description

It has been reported to philips that an operator received an electric shock while preparing the system for clinical use.The operator was taken to the emergency department and a mild blockage was detected on the ecg performed.

Manufacturer Narrative

Philips investigated this complaint.Philips has confirmed with the hospital that the operator was kept under observation for a few hours and discharged.The operator has resumed normal activity at the hospital.Philips inspected the system on (b)(6)2019.During this inspection, it was identified that the mains power cable was modified and was not according to philips specifications.The main voltage connections of the system were without a proper ground connection.This resulted in a short circuit and upon touching the system, the operator received an electrical shock.Philips has replaced the mains power cable, wired this cable according to philips specifications, performed all safety checks, and has returned the system to use in good working order.Our investigation also included the review of the service records.Philips performed a preventive maintenance on the same system on (b)(6)2019 that included verification of the integrity of the mains power cable and electrical safety checks.All checks passed satisfactorily.No other service activity has been requested to philips until the service provided on (b)(6)2019.Philips will inform the customer about the results of this investigation, including the need to perform repairs and maintenance according to philips specifications.Based on the investigation results, philips has concluded that this is a non-adverse event.Consequently, philips has closed this complaint.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

Corrected data updated section b1 to product problem based on information provided submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: BV LIBRA, MOBILE X-RAY UNIT
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 9503894
• MDR Text Key: 174312204
• Report Number: 3003768277-2019-00106
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• PMA/PMN Number: K010762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2019

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
• Device Operator: Health Professional
• Device Model Number: 718022
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/17/2019; 12/17/2019
• Supplement Dates FDA Received: 02/06/2020; 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 68