MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-07-21 for OLYMPIC BILI-METER 50075-T507 manufactured by Natus Medical Incorporated.
[80701274]
Natus medical has launched an investigation into this event and will file a supplemental report once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[80701275]
Natus medical received a complaint on (b)(6) 2017 that their bili-meter was tested by an outside laboratory and claims reading are measurement too high. A request has been made to return the product for evaluation and calibration. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2017-00483 |
| MDR Report Key | 6733225 |
| Report Source | USER FACILITY |
| Date Received | 2017-07-21 |
| Date of Report | 2017-06-21 |
| Date Mfgr Received | 2017-06-21 |
| Device Manufacturer Date | 2016-03-22 |
| Date Added to Maude | 2017-07-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MARC RIVAS |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685142 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPIC BILI-METER |
| Generic Name | OLYMPIC BILI-METER |
| Product Code | MQM |
| Date Received | 2017-07-21 |
| Model Number | 50075-T507 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Brand Name | OLYMPIC BILI-METER |
| Generic Name | OLYMPIC BILI-METER |
| Product Code | JJQ |
| Date Received | 2017-07-21 |
| Model Number | 50075-T507 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-21 |