MAUDE Adverse Event Report: NATUS NEURO INCORPORATED NICOLET ELITE; ELITE AUTO SHUT-OFF 200R MAIN

Model Number	XMD008
Medical Device Problem Codes	Device Sensing Problem (2917); Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference (b)(4).Customer states there is excessive noise when trying to hear the fetal heartbeat.Customer was provided a quote for repair on the unit on (b)(6), 2019.Additional attempt to collect product made on (b)(6), 2019 where customer confirmed they were still in possession and planned on returning unit.Adverse event questionnaire sent to customer for additional follow up on patient involvement on (b)(6) and (b)(6), 2019.
Event or Problem Description
Noise prevents user from being able to hear fetal heartbeat.
Additional Manufacturer Narrative
Reference (b)(4).Device returned to natus on december 26, 2019.Per depot repair notes: "replaced the speaker, the front housing and the probe cable.Installed a new battery and tested, the unit passed all functional tests.The probe was evaluated and there were no probelms found with the probe.".

• Brand Name: NICOLET ELITE
• Common Device Name: ELITE AUTO SHUT-OFF 200R MAIN
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 9512785
• Report Number: 3010611950-2019-00077
• Device Sequence Number: 3445688
• Product Code: JAF
• UDI-Device Identifier: 00382830028042
• UDI-Public: 00382830028042
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K982635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: XMD008
• Device Catalogue Number: XMD008
• Device Lot Number: ECQ0529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other