MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-26 for HEART-SYNC ADULT RADIOLUCENT T-100 - PHILIPS manufactured by Heart-sync.
[1726434]
Unable to interconnect heart-sync t-100 brand defibrillator electrode to philips brand mrx defibrillator cable connector during preparation for pt care intervention. After various attempts by two clinicians present, the connector stopped 1/2" short from complete contact. After proper pt assessment utilizing a 5 lead cardiac monitor. It was determined defibrillation was not indicated due to a complete asystole arrythmia. Had the pt required electrical therapy, the connector malfunction would have prevented proper clinical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019186 |
| MDR Report Key | 1976594 |
| Date Received | 2011-01-26 |
| Date of Report | 2011-01-26 |
| Date Added to Maude | 2011-02-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEART-SYNC |
| Generic Name | DEFIBRILLATOR ELECTRODE |
| Product Code | DRK |
| Date Received | 2011-01-26 |
| Model Number | ADULT RADIOLUCENT |
| Catalog Number | T-100 - PHILIPS |
| Lot Number | Y122909-22 |
| Device Expiration Date | 2013-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEART-SYNC |
| Manufacturer Address | 5643 PLYMOUTH RD ANN ARBOR MI 48105 US 48105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2011-01-26 |