MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1999-12-17 for HIGH FREQUENCY OSCILLATORY VENTILATOR 3100A 768901 manufactured by Sensormedics Corp..
[21697553]
While treating a pt with the model 3100a, the "oscillator overheat" light came on, and shortly after, the oscillator stopped. The pt was hand-ventilated then placed on another 3100a without compromise.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1999-00120 |
| MDR Report Key | 255693 |
| Report Source | 05,06,07 |
| Date Received | 1999-12-17 |
| Date of Report | 1999-12-16 |
| Date of Event | 1999-12-09 |
| Date Mfgr Received | 1999-12-09 |
| Device Manufacturer Date | 1995-12-01 |
| Date Added to Maude | 1999-12-27 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAUL KITTINGER, DIRECTOR |
| Manufacturer Street | 22705 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 928874645 |
| Manufacturer Country | US |
| Manufacturer Postal | 928874645 |
| Manufacturer Phone | 7142832228 |
| Manufacturer G1 | SENSOR MEDICS CORP |
| Manufacturer Street | 22705 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887464 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92887 4645 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH FREQUENCY OSCILLATORY VENTILATOR |
| Generic Name | NEONATAL/PEDIATRIC VENTILATOR |
| Product Code | LSC |
| Date Received | 1999-12-17 |
| Model Number | 3100A |
| Catalog Number | 768901 |
| Lot Number | - |
| ID Number | - |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 247593 |
| Manufacturer | SENSORMEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PKWY. YORBA LINDA CA 928874645 US |
| Baseline Brand Name | HIGH FREQUENCY OSCILLATORY VENTILATOR |
| Baseline Generic Name | NEONATAL VENTILATOR |
| Baseline Model No | 3100A |
| Baseline Catalog No | 768901 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-12-17 |