MAUDE MDR 563576

MDR report key
563576
Report number
MW4003835
Event key
0
Event type
3
Date received
2004-10-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VAX D*UNKITH***N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-10-220

Event Narratives#

D

Patient 1

PT RECENTLY HAD A VAX D TREATMENT. PT WAS STRAPPED INTO SAFETY BELT AND A SHOULDER COLLAR AND LAID ON MACHINE THE MACHINE TURNED ON. PT SUFFERED A SEVERE SHOOTING PAIN AND HAD NO WAY TO SHUT DOWN THE MACHINE AND THE DR HAD LEFT THE ROOM. PT WAS IN PAIN FOR ANOTHER 5-10 MINS TILL HE RETURNED. PT SUFFERED SEVERE PAIN ON WAY HOME AND STILL FEELS THE PAIN BUT IT HAS LESSENED SOME. POINT IS THERE SHOULD BE A EMERGENCY STOP WITHIN THE REACH OF THE PT SHOULD ANY EMERGENCY ARISE, SHOUTING PAIN OR EVEN A CARDIAC EMERGENCY COULD HAPPEN. HOW HARD WOULD IT BE TO HAVE A PANIC STOP NEXT TO PT'S HAND. PT FEELS THIS MODIFICATION SHOULD BE DONE RIGHT AWAY. THERE IS UP TO 80 LBS OF PRESSURE ON A PT WHEN SOMETHING BAD COULD HAPPEN. DRS ARE DISTRACTED BY PHONE CALLS, OTHER PTS OR EVEN A BATHROOM BREAK AND PT IS STRAPPED TO A MACHINE IN POSSIBLE HARMFUL PAIN.