MAUDE Adverse Event Report: NATUS MEDICAL DENMARK APS (GN OTOMETRICS) AURICAL OTOCAM 300 TYPE 1076

Model Number 8-04-13250

Device Problem Material Fragmentation (1261)

Patient Problem Not Applicable (3189)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

Complete device was returned for repair.Cable issue was confirmed.Natus replaced this with a refurbished otocam, and completed a function test and final test.Justification for not providing below information and applicable sections: part a: patient information - no patient involvement.Relevant tests / laboratory data - this section is not applicable as no patient injury reported.Other relevant history, including preexisting medical conditions: this section is not applicable as no patient injury reported.Lot # - this section is not applicable as the medical device does not have a lot number.Udi - information not available at the time of the report this will be submitted in the follow up report.If implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable.If explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable.Reprocessor name and address - this section is 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) - this section is not applicable to this type of device for use by user facility / importer - not applicable as we are not a facility or importer of device.If nd, give protocol # - this section is not applicable as the medical device is not ind.Adverse event terms - this section is not applicable to medical devices.If remedial action initiated , check type - this section is 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

Damaged cable on the oto cam device, disconnects when cable is straightened out and exposed wires were identified.

Manufacturer Narrative

Investigation results & findings the device was returned for evaluation.Failure was confirmed.The device was replaced with a refurbished otocam.Functional and final testing were conducted.No patient impact was reported.This issue will be continued to be monitored.

• Brand Name: AURICAL OTOCAM 300 TYPE 1076
• Type of Device: AURICAL OTOCAM 300 TYPE 1076
• Manufacturer (Section D): NATUS MEDICAL DENMARK APS (GN OTOMETRICS); hoerskaetten 9,; taastrup, 2630 ; DA 2630
• MDR Report Key: 9309581
• MDR Text Key: 196634106
• Report Number: 9612197-2019-00020
• Device Sequence Number: 1
• Product Code: ERA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2021
• Device Model Number: 8-04-13250
• Device Catalogue Number: 8-04-13250
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other