FDA.reportPublic FDA data

MAUDE MDR 8188893

MDR report key
8188893
Report number
3003768277-2018-00098
Event key
0
Event type
3
Date received
2018-12-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. DUSTY LEPPERT
Address
VEENPLUIS 4-6 P.O. BOX 10.000 BEST 5680 NL
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALLURA XPER FD10SYSTEM, X-RAY, ANGIOGRAPHICPHILIPS HEALTHCAREIZI722010722010Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-210

Event Narratives#

N

Patient 1

WHEN THE INVESTIGATION HAS BEEN COMPLETED PHILIPS WILL INFORM THE FDA.

D

Patient 1

PHILIPS HAS RECEIVED THROUGH (B)(6) A REPORT SUBMITTED ((B)(4)) BY A CUSTOMER. IN THIS REPORT THE CUSTOMER REPORTED: ?THE X-RAY TUBE IN ROOM 5 HAD BEEN REPAIRED, UPDATED DURING THE DAY OF (B)(6) 2018. WAS REPORTED READY FOR USE. WE RE-BOOTED THE SYSTEM AT THE BEGINNING OF THE NIGHT SHIFT DUE TO THAT THE TABLE WAS HARD TO OPERATE (A CREAKING SOUND). HEREAFTER THERE WAS AN ACUTE PATIENT ON THE TABLE WITHOUT X-RAY PROBLEMS. AFTER SOME HOURS A NEW ACUTE PATIENT ARRIVE. BEFORE THIS PATIENT WAS BROUGHT ONTO THE TABLE WE DISCOVERED THAT THE TABLE WAS FLOATING ? MEANING THAT IT WAS MOVING BY THE LEASED TOUCH. THEREFORE IT WAS NOT POSSIBLE TO COMPLETE THE KAG/PCI ON THIS VERY BAD ACUTE PATIENT. HAD TO MOVE THE PATIENT TO ANOTHER ROOM WHICH TOOK APPROX. 10 MIN. NORMALLY ? WHEN TREATING ACUTE PATIENTS ? IT TAKES APPROX.. 5 MIN WHEN THE PATIENT ARRIVE AT THE ROOM UNTIL THE PROCEDURE CAN START?. PHILIPS HAS INITIATED AN INVESTIGATION OF THIS COMPLAINT.