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 1996-11-14 for PULMONARY FUNCTION LABORATORY 2180 manufactured by Sensor Medics Corp..
[34705]
The computer terminal (s/n 1609-0214) for the model 2180 "smoked" according to the user. No pts were involved and there were no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1996-00012 |
| MDR Report Key | 50441 |
| Report Source | 05,06,07 |
| Date Received | 1996-11-14 |
| Date of Report | 1996-11-13 |
| Date of Event | 1996-10-11 |
| Date Mfgr Received | 1996-10-11 |
| Device Manufacturer Date | 1986-01-01 |
| Date Added to Maude | 1996-11-22 |
| 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 | 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 | 1996-11-14 |
| Returned To Mfg | 1996-11-11 |
| Model Number | 2180 |
| Catalog Number | NA |
| 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 | 51147 |
| Manufacturer | SENSOR MEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PKWY YORBA LINDA CA 928874645 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-11-14 |