MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-05 for NICOLET ICU MONITOR 515-019100 manufactured by Natus Neurology Incorporated.
[178156433]
Patient information - no patient injury reported, device malfunction occurred. Date of event - date of event requested from the customer but information not yet provided. Relevant tests / laboratory data - this section is not applicable as no patient injury occurred. Other relevant history, including preexisting medical conditions: this section is not applicable as no patient injury occurred. Suspect products - not applicable. Serial # - this section is not applicable as the medical device does not have a serial number. If implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. If explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. Reprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient. Concomitant medical products and therapy dates (excluding treatment of event) - this section is not applicable to this type of device. For use by user facility / importer - not applicable as we are not a facility or importer of device. If nd, give protocol # - this section is not applicable as the medical device is not ind. Adverse event terms - this section is not applicable to medical devices. If remedial action initiated , check type - this section is not applicable as no remedial action was initiated. If action reported to fda under 21 usc 360i (f), list correction / removal reporting number - this section is not applicable as there was no action reported under 21usc 360i(f).
Patient Sequence No: 1, Text Type: N, H10
[178156474]
Amplifier was very hot and a burn colour (brown) appeared on the back side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2020-00001 |
| MDR Report Key | 9671534 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-30 |
| Date Added to Maude | 2020-02-05 |
| 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 | TONI GORMAN |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD MIDDLETON |
| Manufacturer City | 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer G1 | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD MIDDLETON |
| Manufacturer City | 53562 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53562 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NICOLET ICU MONITOR |
| Generic Name | NICOLET ICU MONITOR |
| Product Code | GWQ |
| Date Received | 2020-02-05 |
| Model Number | 515-019100 |
| Catalog Number | 515-019100 |
| 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 NEUROLOGY INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WISCONSIN 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-05 |