MAUDE Adverse Event Report: PHILIPS HEALTHCARE ALLURA XPER FD10; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 722010

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 03/29/2019

Event Type  Injury  

Manufacturer Narrative

When the investigation has been completed philips will inform the fda.

Event Description

It has been reported to philips that during a procedure on a patient with a heart attack, suddenly fluoroscopy/x-ray were not possible.The patient was transferred to another system in the hospital where the procedure was successfully completed.Transfer of the patient took about 30 minutes.The doctor indicated that the patient might have lost heart tissue due to the delay in performing the procedure.

Manufacturer Narrative

Philips investigated this complaint.Philips analyzed the log file, which showed that the first occurrence of the issue is on (b)(6)2019, the day before the reported event took place.The system is started in the morning and during the startup at an error (timeout establishing connection with the generator) is displayed in the logging that the generator is not available and a triggered user message ¿fluoroscopy not possible.Reselect application¿ was displayed.As mentioned in the ifu (4522 203 16832 allura xper fd series docv.8.X chapter 4.2 error messages.)this means that fluoroscopy and exposure are not available.The customer did not perform any x-ray that day.Only geometry movements were performed.On (b)(6)2019, the day of the reported issue, during the startup in the morning, the same user message is displayed.The customer tried multiple times to perform x-ray and to enable/disable radiation.Also, multiple restarts were performed, which did not solve the problem.On site analysis by philips determined that the mpd (mains power distribution) control unit did not switch on the generator during power-on causing the reported issue.The mpd control unit was not able to signal the generator to turn-on.The mpd control unit was replaced after which the system was returned to use in good working order.Based on trending analysis there is no exceptional replacement rate for the mpd control unit.Philips will take no further actions.Philips did not report similar incident reports.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: ALLURA XPER FD10
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• MDR Report Key: 8490918
• MDR Text Key: 141171503
• Report Number: 3003768277-2019-00029
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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: 722010
• Device Catalogue Number: 722010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 61