FDA.reportPublic FDA data

MAUDE MDR 149274

MDR report key
149274
Report number
MW4002119
Event key
0
Event type
3
Date received
1998-02-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1APOLLO X-RAY TUBE CEILINGX-RAY TUBE CEILING SUSPENSIONPICKER INT'L., INC.ITYNINININ*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11998-02-170

Event Narratives#

D

Patient 1

EXTENSION SHAFT NOT MFG TO ITS DESIGN SPEC. USERS OF APOLLO CEILING SUSPENSIONS SHOULD DETERMINE WHETHER THEIR UNIT IS FITTED WITH AN EXTENSION SHAFT. IF SUCH A SHAFT IS FITTED, THE USER SHOULD CONTACT THEIR SVC PROVIDER TO ARRANGE REPLACEMENT. THE SVC PROVIDER CAN THEN CONTACT PICKER INTL TO ARRANGE SUPPLY OF THE REPLACEMENT PARTS. IF IT IS NECESSARY TO CONTINUE USE OF AN APOLLO FITTED WITH AN EXTENSION SHAFT PRIOR TO ITS REPLACEMENT, USERS SHOULD ENSURE THAT THE EXTENSION SHAFT IS CAREFULLY CHECKED BY A COMPETENT PERSON FOR ANY SIGNS OF WELD DETERIORATION OR WELD FRACTURES. IF THERE IS ANY DOUBT OVER THE EXTENSION SHAFT, USERS SHOULD CONTACT THEIR SVC PROVIDER OR PICKER INTL. A SMALL NUMBER OF APOLLO CEILING SUSPENSIONS WERE FITTED WITH EXTENSION SHAFTS EITHER TO ALLOW FOOT AND ANKLE WORK OR WHERE THERE WAS A HIGH CEILING. MDA HAS REC'D A REPORT OF AN EXTENSION SHAFT FAILING AND INVESTIGATION REVEALED THAT THE SHAFT HAD NOT BEEN CONSTRUCTED TO THE ORIGINAL DESIGN SPEC. PICKER HAS AGREED TO REPLACE, FREE OF CHARGE, ALL EXTENSION SHAFTS WITH NEW SHAFTS TO THE CORRECT SPEC.