MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-06-05 for STETHOSCOPE ESOPHAGEAL WITH ELECTRICAL CONDUCTORS ES400-18 manufactured by Smiths Medical Asd, Inc..
[17441270]
User alleges that attempting to pull esophageal probe back out of the pt the white cord broke. The probe was removed by the doctor "snagging" esophageal stethoscope.
Patient Sequence No: 1, Text Type: D, B5
[17548826]
Evaluation-other: the probe was discarded at the facility. Smiths medical asd, inc is unable to perform a thorough investigation without the return of the actual sample involved. If info is received other than what is reported; then a follow up report will be filed. A review of the complaints database shows no reports on this catalog number or lot number. In addition, a review of mfg records for this catalog number indicated no problems that would provide an explanation for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221261-2006-00017 |
| MDR Report Key | 734485 |
| Report Source | 06 |
| Date Received | 2006-06-05 |
| Date of Report | 2006-06-05 |
| Date of Event | 2006-04-03 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2006-07-17 |
| 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 | 0 |
| Manufacturer Contact | TIM MATSON |
| Manufacturer Street | 10 BOWMAN DR |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal | 03431 |
| Manufacturer Phone | 6033523812 |
| Manufacturer G1 | SMITHS HEALTHCARE MFG S.A. DE C.V. |
| Manufacturer Street | AVE. CALIDAD NO. 4 PRQUE IND. INTERNACIONAL, OTAY |
| Manufacturer City | UNIVERSIDAD TIJUANA, BC 22427 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22427 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STETHOSCOPE ESOPHAGEAL WITH ELECTRICAL CONDUCTORS |
| Generic Name | ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR |
| Product Code | BZT |
| Date Received | 2006-06-05 |
| Model Number | ES400-18 |
| Catalog Number | ES400-18 |
| Lot Number | 5199 |
| ID Number | NA |
| Device Expiration Date | 2009-02-01 |
| 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 | 722356 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 160 WEYMOUTH ST. ROCKLAND MA 02370 US |
| Baseline Brand Name | ES400-18 |
| Baseline Generic Name | TEMPERATURE SENSOR |
| Baseline Model No | ES400-18 |
| Baseline Catalog No | ES400-18 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-05 |