MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-26 for KENDALL 33541 manufactured by Covidien.
[78566601]
An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[78566602]
The customer stated the telemetry was reading sustained v-tach, however upon connecting patient to the defibrillator, the patient was noted to be in a normal sinus rhythm. The telemetry box continued to show sustained v-tach. The telemetry box, adapter, and lead wires were changed on the patient showing sinus rhythm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2017-05188 |
| MDR Report Key | 6667895 |
| Date Received | 2017-06-26 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-02-18 |
| Date Mfgr Received | 2017-02-20 |
| Date Added to Maude | 2017-06-26 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KENDALL |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-06-26 |
| Model Number | 33541 |
| Catalog Number | 33541 |
| Lot Number | 278428 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-26 |