MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-03-09 for ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE ES400-12, ES400-18, ES400-24 manufactured by Sims Portex Inc..
[19898828]
An esophageal stethoscope was used during surgery. One day post-op, the pt allegedly coughed up the balloon that was attached to the distal end of the esophageal stethoscope. The hospital staff were reportedly unaware of any problems prior the pt coughing up the balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020364-2001-00001 |
| MDR Report Key | 320037 |
| Report Source | 05 |
| Date Received | 2001-03-09 |
| Date of Report | 2001-02-05 |
| Date of Event | 2001-02-01 |
| Date Mfgr Received | 2001-02-05 |
| Date Added to Maude | 2001-03-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | BRIAN FARIAS |
| Manufacturer Street | 10 BOWMAN DRIVE |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal | 03431 |
| Manufacturer Phone | 6033523812 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE |
| Generic Name | ESOPHAGEAL STETHOSCOPE |
| Product Code | BZW |
| Date Received | 2001-03-09 |
| Model Number | NA |
| Catalog Number | ES400-12, ES400-18, ES400-24 |
| Lot Number | 1382 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 309563 |
| Manufacturer | SIMS PORTEX INC. |
| Manufacturer Address | 10 BOWMAN DRIVE KEENE NH 03431 US |
| Baseline Brand Name | ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE |
| Baseline Generic Name | ESOPHAGEAL STETHOSCOPE |
| Baseline Model No | NA |
| Baseline Catalog No | ES400-12, ES400-18, ES400-24 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-03-09 |