FDA Adverse Event Malfunction Summary report: N

1081 AURICAL AUD WITH HI-PRO (US ONLY)

MDR report key: 11884232 · Received May 26, 2021

Report

Report Number: 9612197-2021-00008
Event Type: Malfunction
Date Received: May 26, 2021
Date of Event: May 11, 2021
Report Date: December 7, 2021
Manufacturer: NATUS MEDICAL DENMARK
Product Code: EWO
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AK, US
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

FOLLOW UP REPORT 003 ( REF NATUS COMPLAINT# (B)(4)). SECTION D4., UNIQUE IDENTIFIER (UDI) PROVIDED AS (B)(4). WAITING ON THE AFFECTED DEVICE FROM MIDDLETON FOR TIG INVESTIGATION.

Additional Manufacturer Narrative · 0

FOLLOW UP REPORT 002 ( REF NATUS COMPLAINT# (B)(4)) THE INSTALL DATE IN THE INITAL REPORT WAS DOCUMENTED AS APR 2005. THIS INFORMATION HAS BEEN UPDATED ON THE COMPLAINT DETAILS TO THE 12/21/2016 (21 DEC 2016). WAITING ON THE AFFECTED DEVICE FROM MIDDLETON FOR TIG INVESTIGATION.

Additional Manufacturer Narrative · 0

FOLLOW UP REPORT 001 ( REF NATUS COMPLAINT# (B)(4). AWAITING RETURN OF THE AFFECTED DEVICE FOR EVALUATION.

Additional Manufacturer Narrative · 0

FOLLOW UP REPORT 004 (REF NATUS COMPLAINT# (B)(4)). THE AFFECTED DEVICE WAS RETURNED FOR INVESTIGATION AND THE FOLLOWING WAS DOCUMENTED: THE AURICAL AUD DEVICE WAS INVESTIGATED THOROUGHLY. THE TIG TEAM WAS UNABLE TO RECREATE THE FAILURE REPORTED BY THE CUSTOMER. THE TIG TEAM HAS NOT FOUND ANY ISSUES WITH THE DEVICE OR MEASURED ANY HIGH LEVELS THAT COULD CAUSE A HIGH ELECTRIC DISCHARGE. A SEARCH FOR SERVICE DATA THAT MAY BE RELEVANT TO THIS ISSUE HAS BEEN CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE FOUND. INVESTIGATION RESULT CODE: TAASTRUP/NO FAULT FOUND CLOSURE RATIONALE: COMPLAINT VERIFIED, BEING TRACKED AS A TREND.

Additional Manufacturer Narrative · 0

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). CUSTOMER REPORTS CONNECTING TO HIPRO CAUSING SHOCKS TECHNICAL SERVICE CONFIRMS - AURICAL HIPRO RIGHT PORT IS CAUSING ELECTRIC SHOCKS WHEN TRYING TO CONNECT. - ALREADY USED WIRES ON ANOTHER HIPRO AND THEY WERE FINE, SO ISSUE APPEARS TO BE IN HIPRO/AUD - FOR SAFETY NOT ATTEMPTING ANY FURTHER TROUBLESHOOTING AND SENDING TO GNO - RECOMMENDING NOT USING AURICAL AS IT MAY BE DANGEROUS. THE CURRENT RISK FILE 1081 AURICAL AUD & MADSEN A450 - RISK ANALYSIS - (B)(4) REV 02, HAZARD ID 4.14 IDENTIFIES THIS ISSUE. HARM - "USER OR OTHERS COULD BE SEVERELY INJURED OR DIE. CAUSE- "INADEQUATE DESIGN DUE TO INSUFFICIENT INSULATION OF PROGRAMMING CABLE AND CONNECTOR. SEVERITY- CRITICAL (11). RISK LEVEL- MODERATE (33). THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. DEVICE HISTORY RECORD HAS BEEN REVIEWED, INSTALL DATE APR 2005. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS (B)(4) CORPORATE TRENDING AND ANALYSIS PROCEDURE) COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW (B)(4). NO TREND FOR THIS DEVICE IDENTIFIED. CUSTOMER HAS BEEN ADVISED TO RETURN THE DEVICE FOR INVESTIGATION.