MAUDE Adverse Event Report: NATUS NEUROLOGY INCORPORATED ELITE

Model Number X1L001

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information - no patient injury reported, device malfunction occurred.Relevant tests / laboratory data - not applicable as no patient injury occurred.Other relevant history, including preexisting medical conditions: not applicable as no patient injury occurred.Suspect products - not applicable.Serial # - not applicable as the medical device does not have a serial number.If implanted date (mm/dd/yyyy) - not applicable as the medical device is not implantable.If explanted date (mm/dd/yyyy) - not applicable as the medical device is not implantable.Reprocessor name and address - 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) - not applicable to this type of device.Importer - not applicable as we are not a facility or importer of device.If nd, give protocol # - not applicable as the medical device is not ind.Adverse event terms - not applicable to medical devices.If remedial action initiated , check type - 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).

Event Description

Customer's probe head is not picking up fetal tones.

Manufacturer Narrative

Investigation results & findings - natus complaint reference # (b)(4).Product examination and functional testing product was received on april 06.On (b)(6) 2020, a request was submitted to depot repair to accelerate repair of device.Response received from depot repair indicated that in error , the part was scrapped.Due to this, it was not possible to evaluate the unit to verify failure.Capa trending review - review of part number shows related capa003164.Capa003164 was initiated to investigate issues with elite 200 with the 3 mhz probes.Findings from capa003164 indicated that the micro commercial components (mcc) version of the mmbt3904 do not work in the 3mhz elite probe design, while the fairchild semiconductor mmbt3904 do work.Complaint trending review: per qms-004442 complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.No complaint trends have been identified.Risk management file review: reference spg ras spreadsheet, hazard id 5.32 - effect - cannot complete exam, or incorrect diagnosis.Zard is 3 and residual risk is deemed acceptable.Dhr review - the associated dhr was reviewed and there were no anomalies identified.Service record review: service repair investigations will be conducted during the repair process and trend data will be reviewed per qms-004442.This isssue will be continued to be monitored.

Event Description

Customer's probe head is not picking up fetal tones.

• Brand Name: ELITE
• Type of Device: ELITE
• Manufacturer (Section D): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view road; middleton,; wisconsin 53562, usa,
• MDR Report Key: 9892041
• MDR Text Key: 225472385
• Report Number: 3010611950-2020-00009
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K993939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: X1L001
• Device Catalogue Number: X1L001
• Device Lot Number: ECU0100 / CAT1567
• Patient Sequence Number: 1