MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-10 for ESOPHAGEAL PACING STETHOSCOPE ZA * manufactured by Arzco Medical Systems, Inc..
[45369]
Esophageal pacing stethoscope was in place. When electrocautery machine was turned on, it caused the pacemaker to be blocked out. Changed out boxes and it recurred. No pt injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001812 |
| MDR Report Key | 77815 |
| Date Received | 1997-01-10 |
| Date of Report | 1996-09-20 |
| Date of Event | 1996-09-16 |
| Date Added to Maude | 1997-03-25 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOPHAGEAL PACING STETHOSCOPE |
| Generic Name | ESOPHAGEAL PACING STETHOSCOPE |
| Product Code | BZT |
| Date Received | 1997-01-10 |
| Returned To Mfg | 1996-09-17 |
| Model Number | ZA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 77462 |
| Manufacturer | ARZCO MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 5660-G W. CYPRESS ST. TAMPA FL 33607 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-01-10 |