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 1996-10-31 for AUTOBOX 2800 117-2001 manufactured by Sensor Medics Corp..
[16145698]
While a pt was breathing on the device, some small, rubber pieces of material ended up in the pt's mouth. No harm occurred to the pt as she simply spit out all of the rubber pieces. No medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1996-00009 |
| MDR Report Key | 47294 |
| Report Source | 05,06,07 |
| Date Received | 1996-10-31 |
| Date of Report | 1996-10-30 |
| Date of Event | 1996-10-04 |
| Date Mfgr Received | 1996-10-04 |
| Device Manufacturer Date | 1988-05-01 |
| Date Added to Maude | 1996-11-08 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOBOX |
| Generic Name | PRESSURE/VOLUME PLETHYMOGRAPH |
| Product Code | CCM |
| Date Received | 1996-10-31 |
| Model Number | 2800 |
| Catalog Number | 117-2001 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 48093 |
| Manufacturer | SENSOR MEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PKWY YORBA LINDA CA 928874645 US |
| Baseline Brand Name | AUTOBOX |
| Baseline Generic Name | BODY PLETHYSMOGRAPH |
| Baseline Model No | 2800 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-31 |