MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-02 for ONESTEP ELECTRODES 8900-0224-01 manufactured by Zoll Medical Corporation..
[115820080]
The zoll onestep adult electrodes have a wire cable/connector within them that is necessary to test the defibrillator machine. Often times this wire is cracked or broken and when they are hooked up to the machine they give a low voltage error/test failed. I understand that they still will deliver a shock to the patient but what happens if it were not to do that? I am not comfortable proceeding with attempting to shock my patient when the machine is telling me the test failed. I don't like relying on the fact that "well it still delivers a shock--there is no need to worry... " i think that the wire connector is in a bad location. They crack/break during storage, handling and when users are trying to connect the cable to the defibrillators machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7742401 |
| MDR Report Key | 7742401 |
| Date Received | 2018-08-02 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-07-08 |
| Report Date | 2018-07-17 |
| Date Reported to FDA | 2018-07-17 |
| Date Reported to Mfgr | 2018-08-02 |
| Date Added to Maude | 2018-08-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONESTEP ELECTRODES |
| Generic Name | ADULT ELECTRODES, EXTERNAL DEFIBRILLATORS |
| Product Code | LIX |
| Date Received | 2018-08-02 |
| Catalog Number | 8900-0224-01 |
| Lot Number | 2218A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION. |
| Manufacturer Address | 269 MILL ROAD CHELMSFORD MA 01824 US 01824 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-02 |