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 2001-10-15 for AUTOBOX DL 62/6200/V62 769501 manufactured by Sensormedics Corporation.
[232875]
The operator of the autobox noticed a burning smell coming from one of its control modules. There was no patient involvement and no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-2001-00079 |
| MDR Report Key | 356468 |
| Report Source | 05,06,07 |
| Date Received | 2001-10-15 |
| Date of Report | 2001-10-15 |
| Date of Event | 2001-10-01 |
| Date Mfgr Received | 2001-10-01 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2001-10-22 |
| 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 | PAUL KITTINGER, DIRECTOR |
| Manufacturer Street | 22705 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7142832228 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOBOX DL |
| Generic Name | PLETHYSMOGRAPH |
| Product Code | CCM |
| Date Received | 2001-10-15 |
| Model Number | 62/6200/V62 |
| Catalog Number | 769501 |
| Lot Number | - |
| ID Number | - |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SENSORMEDICS CORPORATION |
| Manufacturer Address | 22705 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Baseline Brand Name | AUTOBOX DL |
| Baseline Generic Name | PLETHYSMOGRAPH |
| Baseline Model No | 62/6200/V62 |
| Baseline Catalog No | 769501 |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K923984 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-10-15 |