MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-07 for OLM INTRACRANIAL PRESSURE MONITORING KIT 1104B manufactured by Natus Medical Incorporated.
Report Number | 2023988-2020-00002 |
MDR Report Key | 9681023 |
Report Source | OTHER |
Date Received | 2020-02-07 |
Date of Report | 2020-03-06 |
Date Mfgr Received | 2020-01-22 |
Date Added to Maude | 2020-02-07 |
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 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MICHELLE GREANEY |
Manufacturer Street | NATUS MANUFACTURING LTD IDA BUSINESS PARK |
Manufacturer City | GORT, H91PD92 |
Manufacturer Country | EI |
Manufacturer G1 | NATUS MEDICAL INCORPORATED |
Manufacturer Street | 5955 PACIFIC CENTER BLVD. |
Manufacturer City | SAN DIEGO CA 92121 |
Manufacturer Country | US |
Manufacturer Postal Code | 92121 |
Single Use | 3 |
Remedial Action | OT |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | OLM INTRACRANIAL PRESSURE MONITORING KIT |
Generic Name | OLM INTRACRANIAL PRESSURE MONITORING KIT, PRODUCT CODE: GWM |
Product Code | GWM |
Date Received | 2020-02-07 |
Model Number | 1104B |
Catalog Number | 1104B |
Lot Number | 1041013-I09 |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | NATUS MEDICAL INCORPORATED |
Manufacturer Address | 5955 PACIFIC CENTRE BLVD SAN DIEGO 92121 US 92121 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-02-07 |