MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-18 for SPECTROMETER manufactured by Perkin Elmer Health Sciences Canada, Inc..
| Report Number | MW5091162 |
| MDR Report Key | 9341648 |
| Date Received | 2019-11-18 |
| Date of Report | 2019-11-16 |
| Date of Event | 2014-05-14 |
| Date Added to Maude | 2019-11-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 0 |
| Brand Name | SPECTROMETER |
| Generic Name | ELECTRICAL IMPEDANCE SPECTROMETER |
| Product Code | ONV |
| Date Received | 2019-11-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERKIN ELMER HEALTH SCIENCES CANADA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Hospitalization; 3. Life Threatening; 4. Other; 5. Deathisabilit | 2019-11-18 |