MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-06-17 for ES400-18 manufactured by Level 1, Inc..
[20522922]
User facility went to remove the esophageal stethoscope temperature sensor from the patient, the large end of the silicone sheath broke off and user facility could not remove it from the patient. The patient passed the piece the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221261-2003-00040 |
| MDR Report Key | 467422 |
| Report Source | 05,06 |
| Date Received | 2003-06-17 |
| Date of Report | 2003-06-17 |
| Date Mfgr Received | 2003-06-03 |
| Date Added to Maude | 2003-06-25 |
| 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 | VERNON TRIMBLE |
| Manufacturer Street | 160 WEYMOUTH ST. |
| Manufacturer City | ROCKLAND MA 02370 |
| Manufacturer Country | US |
| Manufacturer Postal | 02370 |
| Manufacturer Phone | 7818788011 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ES400-18 |
| Generic Name | TEMPERATURE SENSOR |
| Product Code | BZT |
| Date Received | 2003-06-17 |
| Model Number | ES400-18 |
| Catalog Number | ES400-18 |
| Lot Number | NI |
| ID Number | * |
| 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 | 456368 |
| Manufacturer | LEVEL 1, 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 | 2003-06-17 |