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

Model Number 722010

Device Problems Loss of Power (1475); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

The user hit shunt trip accidently.When the investigation has been completed, philips will inform the fda.

Event Description

Philips received a complaint where it was reported to philips that: while the user was preparing the patient, the patient was starting to code and by accident the shunt trip was hit.The user hit the shunt trip because he/she thought it was to alert the department to the code on the patient, he/she did not realize it was to remove power from the equipment.The procedure was canceled and the patient was brought back to the coronary care unit.At this moment, philips did not receive patient details.

Manufacturer Narrative

Philips investigated this complaint.The shunt trip (emergency power button) was pressed when the patient entered into cardiopulmonary arrest and the user wanted to alert the resuscitation team.When the shunt trip (emergency power button) was pressed there was no power delivered to the system anymore, resulting in the system not being operative.An electrician on site reset all breakers and the ups breaker and the system was operative again.The shunt trip is not a function offered by philips and is not part of the philips system, but hospitals may install it to remove the power of the system in cases of emergency.The resuscitation alarm is not a philips function either.During the investigation philips was informed that the procedure was canceled and the patient was transferred to the coronary care unit (ccu).The patient regained consciousness and was put on oxygen.The procedure was continued the next day.Because philips received this additional information about the patient we changed the classification of the complaint into serious injury.Philips was informed that condition of the patient is stable.There was no malfunction of the system.No further actions will be taken by philips.

• 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
• 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: 7062782
• MDR Text Key: 93689158
• Report Number: 3003768277-2017-00103
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K041949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2012
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Weight: 73