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MAUDE MDR 679904

MDR report key
679904
Report number
679904
Event key
0
Event type
3
Date of event
2005-12-27
Date received
2006-02-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HI-LO TREATMENT TABLETREATMENT TABLE, PHYSICAL THERAPYDYNATRONICS CORPORATIONJFBHL3E**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-02-010

Event Narratives#

D

Patient 1

PATIENT REQUESTED TO LAY ON A HI-LO TREATMENT TABLE. THE SURFACE OF THIS TABLE IS DIVIDED INTO THREE EQUAL SECTIONS. THE HEAD AND FOOT SECTIONS CAN ADJUST SO THEY CAN BE RAISED UP OR DROPPED DOWN. WHILE THE PATIENT WAS IN THE PROCESS OF LAYING DOWN ON THE TABLE, THE HEAD SECTION WHICH WAS INITIALLY RAISED UP TO 45 DEGREES, DROPPED DOWN 45 DEGREES. PATIENT WAS ASSISTED BACK UP TO SITTING POSITION ON THE EDGE OF THE TABLE. AFTER A FEW MINUTES, PATIENT COMPLAINED OF INCREASED RIGHT LOWER BACK PAIN. ICE AND AN EARLY END TO THE TREATMENT SESSION WERE OFFERED, BUT PATIENT WISHED TO FINISH HER SESSION. PATIENT INDICATED SHE WOULD ICE BACK AT HOME. THE TABLE WAS BROUGHT TO MAINTENANCE FOR EVALUATION. MAINTENANCE WAS UNABLE TO DUPLICATE THE INCIDENT, BUT DID DISCOVER THAT THE SHOCK FOR THE HEAD SECTION REQUIRED REPLACEMENT. HEAD SHOCK, HANDLE AND CUSHION BOLTS WERE REPLACED. OPERATION TESTS OKAY AND TABLE PLACED BACK IN SERVICE.