MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 1996-09-24 for PULMONARY FUNCTION LABORATORY 2200 765985 manufactured by Sensor Medics Corp..
[38679]
The vacuum pump for the nitrogen analyzer used in the model 2200 was making a loud grinding noise and a burning smell was noticed. There were no injuries or harm caused to anyone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1996-90004 |
| MDR Report Key | 56196 |
| Report Source | 04,05,06 |
| Date Received | 1996-09-24 |
| Date of Report | 1996-09-23 |
| Date of Event | 1996-09-10 |
| Date Mfgr Received | 1996-09-10 |
| Device Manufacturer Date | 1991-11-01 |
| Date Added to Maude | 1996-12-18 |
| 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 | PULMONARY FUNCTION LABORATORY |
| Generic Name | PULMONARY TESTING SYSTEM |
| Product Code | BZC |
| Date Received | 1996-09-24 |
| Returned To Mfg | 1996-09-16 |
| Model Number | 2200 |
| Catalog Number | 765985 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 56719 |
| Manufacturer | SENSOR MEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PARKWAY 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 | 1996-09-24 |