MAUDE Adverse Event Report: PHILIPS HEALTHCARE MD ELEVA FD; SYSTEM, X-RAY, STATIONARY

Model Number 708038

Device Problems Loose or Intermittent Connection (1371); Inappropriate/Inadequate Shock/Stimulation (1574); Noise, Audible (3273)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

Philips has investigated this complaint.Several factors contributed to the shock received by the field service engineer: non-routine troubleshooting: a screw was not tightened enough to ensure a secure connection between the k1 relay to the enf1 breaker, causing field service engineer to start troubleshooting.The field service engineer did not use personal protective equipment or electrical safety gloves while working on unprotected energized circuits.The non-routine troubleshooting has to be performed by the fse due to a factory assembly failure because of which the screw was not tightened enough.Philips checked the assembly process for tightening of the screw and found no issues.Employees involved in the assembly process have received additional training to check that the screws are properly tightened.The sequence of events leading to the shock could not be reproduced.No similar complaints have been identified.Philips concludes that this is an isolated case.Philips has reviewed the velara repair manual and confirmed that it describes safety precautions to be undertaken by the field service engineer to avoid electrical shock during service work.Following this event, philips has issued an additional internal safety alert on november 8, 2019, describing this situation and the safety related precautions that field service engineers need to follow in such situations.

Event Description

It has been reported to philips that during installation of a new velara generator on (b)(6) 2019, the field service engineer noticed the generator was making an arcing noise.He began troubleshooting and found that the jumper between enf1 and k1 was loose.According to the philips field service engineer, he was reaching across and under the generator transformer when his forearm came in contact with the transformer coil resulting in a 480v shock, which entered his forearm, travelled across his body and exited his other arm.The field service engineer experienced numbness in his fingers and was able to return to work after a positive ecg evaluation.

• Brand Name: MD ELEVA FD
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 9516505
• MDR Text Key: 181523144
• Report Number: 3003768277-2019-00109
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 708038
• Device Catalogue Number: 708038
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1