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 1996-11-22 for PULMONARY FUNCTION LABORATORY 2400 21334 manufactured by Sensor Medics Corp..
[32206]
The user reported a burning smell after the model 2400 was turned on. There were no pts involved and no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1996-00027 |
| MDR Report Key | 53326 |
| Report Source | 05,06,07 |
| Date Received | 1996-11-22 |
| Date of Report | 1996-11-20 |
| Date of Event | 1996-10-30 |
| Date Mfgr Received | 1996-10-30 |
| Device Manufacturer Date | 1987-11-01 |
| Date Added to Maude | 1996-12-05 |
| 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 FUNCTION TESTER |
| Product Code | BZC |
| Date Received | 1996-11-22 |
| Returned To Mfg | 1996-11-06 |
| Model Number | 2400 |
| Catalog Number | 21334 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 53940 |
| Manufacturer | SENSOR MEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PKWY YORBA LINDA CA 928874645 US |
| Baseline Brand Name | PULMONARY FUNCTION LAB |
| Baseline Generic Name | PULMONARY FUNCTION TESTER |
| Baseline Model No | 2400 |
| Baseline Catalog No | 21334 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-11-22 |