MEDTRONIC REUSABLE EXTENSION CABLE 53912

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-09-13 for MEDTRONIC REUSABLE EXTENSION CABLE 53912 manufactured by Oscor Inc..

Event Text Entries

[54632807] Per information received by the customer, the device was not in use at the time the failure was noticed. To date, the device has not returned for evaluation; as a result, the allegations against this cable cannot be confirmed. A review of the device history records could not be performed as the lot number of the device is unknown. As the device was not returned for analysis, the root cause of the failure could not be determined. Potential cause of this failure: insufficient strength of soldered joint. Since the separation between the cable wire and the soldered pin may cause a disruption of the cable function, a corrective and preventive action has been opened to address this failure. Per the cable inspection procedure, during in process inspection the cable is inspected 100% for continuity. During final inspection, each strand of the cable is checked for the correct colored part, overall length of the cable, cable checked for damage and insulation voids, verification that the silicone strain relief extends at least for a length of 2 cm outside the female connector, checked that the silicone strain relief fits the wire snugly, checks for strain relieves for damage and gaps, a pull test is done on each connector and pin and the cable is inspected again for continuity. The instructions for use (ifu) informs the user: for reusable cables only: the cables can be re-sterilized by oscor eto gas sterilization a maximum of two times. The directions for use inform the user to: first attach the proximal connector(s) to a pacemaker/analyzer or another extension cable while observing polarity indicated by the color. Then attach the distal connector(s) to the temporary lead connector or to another extension cable, again observing polarity by the color. The detachment of the connection should be done in the reverse order. Precautions include: do not connect any cable model to a/c power source; connection of exposed pins to a/c power source may pose a risk of serious injury or death. Extension cables are not intended for use with apnea monitors.
Patient Sequence No: 1, Text Type: N, H10


[54632808] The customer reported that the wires of the cable were fractured. At the time of occurrence, there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1035166-2016-00153
MDR Report Key5947209
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2016-09-13
Date of Report2016-08-15
Date of Event2016-07-29
Date Mfgr Received2016-08-15
Date Added to Maude2016-09-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS DORIT SEGAL
Manufacturer Street3816 DESOTO BLVD.
Manufacturer CityPALM HARBOR FL 346831618
Manufacturer CountryUS
Manufacturer Postal346831618
Manufacturer Phone7279372511
Manufacturer G1OSCOR INC.
Manufacturer Street3816 DESOTO BLVD.
Manufacturer CityPALM HARBOR FL 346831816
Manufacturer CountryUS
Manufacturer Postal Code346831816
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDTRONIC REUSABLE EXTENSION CABLE
Generic NameELECTRODE CABLE
Product CodeIKD
Date Received2016-09-13
Model Number53912
Catalog Number53912
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOSCOR INC.
Manufacturer Address3816 DESOTO BLVD. PALM HARBOR FL 346831816 US 346831816


Patients

Patient NumberTreatmentOutcomeDate
10 2016-09-13

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