MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED OLYMPIC BILI-METER

Model Number 50075-T507

Device Problems Low Readings (2460); Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Natus medical has launched an investigation into this event and will file a supplemental report once the investigation is complete.

Event Description

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.

• Brand Name: OLYMPIC BILI-METER
• Type of Device: OLYMPIC BILI-METER
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• Manufacturer (Section G): NATUS MEDICAL INCORPORATED; 5900 first avenue south; seattle WA 98108
• Manufacturer Contact: marc rivas ; 5900 first avenue south; seattle, WA 98108 ; 2062685142
• MDR Report Key: 6733225
• MDR Text Key: 80701274
• Report Number: 3018859-2017-00483
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 50075-T507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other