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 1996-09-05 for PULMONARY FUNCTION LABORATORY 2200 765985 manufactured by Sensors Medics Corp.
[16292246]
Vacuum pump pressure relief box was rattling. When touch by an operator, a spark was emitted and the circuit breaker tripped. There were no injuries and no pts were reported to be involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1996-90001 |
| MDR Report Key | 47223 |
| Report Source | 05,06,07 |
| Date Received | 1996-09-05 |
| Date of Report | 1996-09-04 |
| Date of Event | 1996-08-28 |
| Date Mfgr Received | 1996-08-28 |
| Device Manufacturer Date | 1991-11-01 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| 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 | PULMONARY FUNCTION LABORATORY |
| Generic Name | PULMONARY TESTING SYSTEM |
| Product Code | BZC |
| Date Received | 1996-09-05 |
| Model Number | 2200 |
| Catalog Number | 765985 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 48026 |
| Manufacturer | SENSORS MEDICS CORP |
| Manufacturer Address | 22705 SAVI RANCH PKWY YORBA LINDA CA 928874645 US |
| Baseline Brand Name | PULMONARY FUNCTION LAB |
| Baseline Generic Name | PULMONARY TESTING SYSTEM |
| Baseline Model No | 2200 |
| Baseline Catalog No | 765985 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K923988 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-09-05 |