MAUDE Adverse Event Report: NATUS NEURO INCORPORATED NICOLET VERSALAB APM/APM2; VERSALAB APM SINGLE

Model Number XVLB03

Device Problems Device Sensing Problem (2917); Environmental Compatibility Problem (2929)

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

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Reference (b)(4).Customer was asked to provide additional information level of patient involvement and additional details of the complaint provided via adverse event questionnaire on december 12 and december 19, 2019.Customer returned the questionnaire confirms that no additional medical intervention was required as patients were referred to a different site for testing.Customer was asked to confirm on december 23 if they will be able to return the product to natus for additional evaluation.

Event Description

User unable to hear fetal heartbeat.

• Brand Name: NICOLET VERSALAB APM/APM2
• Type of Device: VERSALAB APM SINGLE
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer Contact: janessa boone ; 3150 pleasant view road; middleton, WI 53562 ; 6088298603
• MDR Report Key: 9512905
• MDR Text Key: 172862209
• Report Number: 3010611950-2019-00078
• Device Sequence Number: 1
• Product Code: LXE
• UDI-Device Identifier: 00382830027885
• UDI-Public: 00382830027885
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XVLB03
• Device Catalogue Number: XVLB03
• Device Lot Number: AVS0105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other