MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-03-08 for MEDTRONIC REUSABLE EXTENSION CABLE 53912 manufactured by Oscor Inc..
[69445395]
This complaint is part of internal retrospective review of complaints received from march 2014 to march 2016, conducted by oscor as a result of process improvements made to the complaint system to ensure proper medical device reporting is maintained. As part of the detailed review, this event has been determined to be reportable. This initial mdr is being submitted to meet our requirements of reporting. The cable was not returned for analysis. A review of the device history record (dhr) could not be performed as the lot number of the cable was not provided. As the device was not returned, however, the cause of the cable failure is determined to be a weak cable-to-connector solder joint. The potential cause of this failure may be: insufficient strength of soldering and crimping of connectors to the cable wire. The potential effect to the user/device may be: disruption of the cable function. A corrective and preventive action has been opened to address this failure. Oscor will continue to monitor this device for complaint trends and risk. Review of the atar mdts cable inspection procedure identified that inspection of the following is done per 100%: each strand of the cable is checked for the correct colored part, cable is measured and verified for overall length, cable is checked for damage and insulation voids, the inspector verifies that the silicone strain relief extends at least for a length of 2 cm outside the female connector, the silicone strain relief is checked so that it fits the wire snugly, strain relieves are checked for damage and gaps, and pull test to verify strength of soldered joint. The cable is also 100% inspected for continuity and for proper connector function. The instructions for use (ifu) informs the user that the cable can be re-sterilized by oscor eto gas sterilization a maximum of two times. Precautions are provided to the user: 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.
Patient Sequence No: 1, Text Type: N, H10
[69445396]
It was reported that while the patient was using a single chamber external pulse generator (epg) the nurse lifted the device cot-side and broke the temporary pacemaker cable. Only the cable was returned to the manufacturer. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1035166-2017-00020 |
| MDR Report Key | 6389216 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-03-08 |
| Date of Report | 2017-03-08 |
| Date of Event | 2014-07-23 |
| Date Mfgr Received | 2016-09-21 |
| Date Added to Maude | 2017-03-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS DORIT SEGAL |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal | 346831816 |
| Manufacturer Phone | 7279372511 |
| Manufacturer G1 | OSCOR INC. |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 346831816 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 346831816 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC REUSABLE EXTENSION CABLE |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-03-08 |
| Model Number | 53912 |
| Catalog Number | 53912 |
| Lot Number | UNK |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSCOR INC. |
| Manufacturer Address | 3816 DESOTO BLVD. PALM HARBOR FL 346831816 US 346831816 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5391 | 2017-03-08 |