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 |