CARDIOTRONIC OSYPKA MEDICAL XI.MDT REUSABLE EXTENSION CABLE

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 2017-05-22 for CARDIOTRONIC OSYPKA MEDICAL XI.MDT REUSABLE EXTENSION CABLE manufactured by Oscor Inc..

Event Text Entries

[75722290] The device was not returned, as a result, the reported failure cannot be confirmed. The device history record (dhr) was reviewed and no rejects were recorded. There were two other complaints reported against this lot number. Since the cable was not returned for analysis, the root cause of the cable failure could not be confirmed. The potential cause may be: insufficient strength joint. The potential effect to the user/device may be: disruption of the cable function, cable cannot be used properly, and delaying the procedure. Based on this investigation a capa has been opened to address failure. Oscor will continue to monitor this device for complaint trends and risk. Per 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


[75722291] The customer reported one of the individual cables detached easily from its connector part (in this case, the red connector). They reported the same problem on two other xi. Mdt cables (out of 6 cable shipped), all of which are not any more on hand. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1035166-2017-00036
MDR Report Key6583143
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2017-05-22
Date of Report2017-05-22
Date of Event2015-05-01
Date Mfgr Received2015-05-14
Device Manufacturer Date2015-02-11
Date Added to Maude2017-05-22
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 346831816
Manufacturer CountryUS
Manufacturer Postal346831816
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 NameCARDIOTRONIC OSYPKA MEDICAL XI.MDT REUSABLE EXTENSION CABLE
Generic NameCABLE, ELECTRODE
Product CodeIKD
Date Received2017-05-22
Model NumberXI.MDT
Catalog NumberXI.MDT
Lot NumberD2-02867
Device Expiration Date2018-02-01
OperatorNURSE
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerOSCOR INC.
Manufacturer Address3816 DESOTO BLVD. PALM HARBOR FL 346831816 US 346831816


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-22

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