FDA.reportPublic FDA data

MAUDE MDR 5540478

MDR report key
5540478
Report number
8030876-2016-00001
Event key
0
Event type
3
Date of event
2016-02-20
Date received
2016-04-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. LARS MORING
Address
ASENTAJANKATU 6 HELSINKI, 00880 FI
Phone
20-20-20 7
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PLANMECA PROONEPLANMECA PROONEPLANMECA OYMUHFE001583R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-0101. O

Event Narratives#

N

Patient 1

INVESTIGATIVE ACTIONS: THE EVENT HAD BEEN STORED ON VIDEO FROM A SECURITY CAMERA NEAR THE PRODUCT. THIS SHOWED CLEARLY THAT AN EXTRA CHAIR HAD BEEN LEFT TO BLOCK THE MOVEMENT OF THE PANORAMIC C-ARM, AND THAT THIS CHAIR WAS REMOVED AFTER JAMMING THE DOWNWARD MOVEMENT. THE SUPPORT WIRES, WHICH NORMALLY ARE TIGHT AND HOLDS UP THE C-ARM WERE THUS DRIVEN A BIT LOOSE AND THE C-ARM DROPPED DOWN AS THE OBSTACLE WAS REMOVED. TECHNICIANS FROM OUR COMPANY AND DEALER VISITED THE CUSTOMER AND CHECKED THE PRODUCT AND ITS FUNCTIONS - ALL WAS AS IT SHOULD BE. USER MANUAL INCLUDES FOLLOWING NOTE, WHICH HAD NOT BEEN FOLLOWED: WHEN POSITIONING SEATED PATIENTS (E.G. IN A WHEELCHAIR) ALWAYS FIRST MOVE THE C-ARM DOWN UNTIL THE PATIENT SUPPORT IS APPROXIMATELY LEVEL WITH THE PATIENT'S MOUTH BEFORE YOU POSITION THE PATIENT IN THE X-RAY UNIT. ROOT CAUSE OF PROBLEM: THE EVENT WAS CAUSED BY AN INCORRECTLY PLACED CHAIR IN THE IMAGING AREA. MAIN CAUSE IS NEGLIGENCE BY USER.

D

Patient 1

THE DENTAL PANORAMIC X-RAY UNIT PLANMECA PROONE WAS USED FOR IMAGING A SITTING CHILD PATIENT. WHEN THE UNIT WAS DRIVEN DOWN, THE IMAGING HEAD WAS DRIVEN AGAINST AN EXTRA CHAIR IN THE IMAGING ROOM. THE DENTIST THEN OBSERVED THE CHAIR AND PULLED IT AWAY, WITH THE CONSEQUENCE THAT THE WHOLE X-RAY IMAGING HEAD PART DROPPED DOWN A BIT (MAYBE TWO INCHES). NO ONE WAS HURT.