MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-06 for OLM INTRACRANIAL PRESSURE MONITORING KIT 1104B manufactured by Natus Medical Incorporated.
| Report Number | 2023988-2020-00007 |
| MDR Report Key | 9802847 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-08 |
| Date Added to Maude | 2020-03-06 |
| 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 H91PD92, |
| Manufacturer Country | US |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5955 PACIFIC CENTER BLVD SAN DIEGO CA 92121 , US |
| 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 | 2020-03-06 |
| Returned To Mfg | 2020-02-12 |
| Model Number | 1104B |
| Catalog Number | 1104B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5955 PACIFIC CENTER BLVD SAN DIEGO 92121 , US SAN DIEGO, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-06 |