MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. INGENUITY CORE128; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 728323

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint (b)(4).

Event Description

This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The customer reported that the indicator light, used during patient examinations, is faulty.After evaluating the system, the philips field service engineer (fse) reported that the replacement of the indicator light was bypassed following a fire incident.This issue is currently under investigation.

Manufacturer Narrative

The customer reported that the indicator light, used during patient examinations, is faulty.The philips field service engineer (fse) reported that the replacement of the indicator light was by-passed following a fire incident.The fse went on site to evaluate the system.The fse determined that the customer had cut the wiring to the x-ray indicator light due to a fire that had occurred after a short circuit in their air conditioner unit in the ct exam room.The customer wired the x-ray indicator light and requested the philips fse to connect it to the x-ray on terminal.There was no ct system malfunction.This incident was a service request by the customer.The system is in clinical use.

• Brand Name: INGENUITY CORE128
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: derrick massuri ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 8540995
• MDR Text Key: 142893697
• Report Number: 1525965-2019-00015
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 728323
• Device Catalogue Number: III
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1