MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-11 for OLM INTRACRANIAL PRESSURE MONITORING KIT 1104B manufactured by Natus Medical Incorporated.
| Report Number | 2023988-2020-00003 |
| MDR Report Key | 9693141 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-11 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-11 |
| 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 CO. GALWAY |
| Manufacturer City | GALWAY IRELAND H91PD92, |
| Manufacturer Country | US |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 6701 KOLL CENTER PARKWAY SUITE 120 PLEASANTON |
| Manufacturer City | CA 94566 USA, |
| Manufacturer Country | US |
| Single Use | 3 |
| 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 |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-02-19 |
| Model Number | 1104B |
| Catalog Number | 1104B |
| Lot Number | 104020-J06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 6701 KOLL CENTER PARKWAY SUITE 120 PLEASANTON CA 92121 USA, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-11 |