MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-02-13 for SUBDURAL POST CRANIOTOMY ICP MONITORING KI 1104G manufactured by Natus Medical Incorporated.
| Report Number | 2023988-2020-00004 |
| MDR Report Key | 9706162 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-13 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-13 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS CLAIRE KENNEDY |
| Manufacturer Street | IDA BUSINESS PARK GORT |
| Manufacturer City | CO. GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer G1 | NATUS MEDICALL INCORPORATED |
| Manufacturer Street | 5955 PACIFIC CENTER BLVD. SAN DIEGO, 92121 USA |
| Manufacturer City | SAN DIEGO, |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBDURAL POST CRANIOTOMY ICP MONITORING KI |
| Generic Name | SUBDURAL POST CRANIOTOMY ICP MONITORING KI |
| Product Code | GWM |
| Date Received | 2020-02-13 |
| Model Number | 1104G |
| Catalog Number | 1104G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 6701 KOLL CENTER PARKWAY SUITE 120 PLEASANTON 92121 USA, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-13 |