ACCUSCREEN ABR/DP TYPE 1077
Report
- Report Number
- 9612197-2022-00009
- Event Type
- Malfunction
- Date Received
- October 26, 2022
- Date of Event
- June 19, 2021
- Report Date
- February 24, 2023
- Manufacturer
- NATUS MEDICAL DENMARK APS
- Product Code
- GWJ
- UDI-DI
- 05713315003974
- PMA / PMN Number
- K122067
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
FOLLOW UP REPORT 002 REF NATUS COMPLAINT#(B)(4). 04 NOV 2022 - CUSTOMER CONTACTED- NO RESPONSE 15 NOV 2022 - CUSTOMER CONTACTED- NO RESPONSE FURTHER INVESTIGATION TO BE CARRIED OUT.
FOLLOW UP REPORT 001 REF NATUS COMPLAINT#(B)(4). 27 OCT 2022 - ADDITIONAL INFORMATION RECEIVED DETAILING THE SERIAL NUMBER AND THE CUSTOMER OF THE DEVICE. CHILD PASSED HEARING TEST AS FALSE NEGATIVE. ADDITIONAL TESTS AFTER THIS. CHILD PASSED HEARING TEST AT 2 YEARS OLD. DATE OF INCIDENT : (B)(6) 2021. DEVICE HAS NO RECORD OF CALIBRATION SINCE INSTALL DATE IN (B)(6) 2019. DEVICE HAS NEVER BEEN RECEIVED FOR EXAMINATION SINCE DATE OF INCIDENT (B)(6) 2021. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS (QMS-004442 CORPORATE TRENDING AND ANALYSIS PROCEDURE) COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW DOC- 060538. NO TREND FOR THIS FAILURE IDENTIFIED THE CURRENT RISK FILE DOC-053250 - 1077 ACCUSCREEN & ALPHA - RISK ANALYSIS REV05 HAZARD ID 5.45 IDENTIFIES THIS ISSUE HARM - DELAY IN USE OF THE SYSTEM OR TREATMENT. CAUSE- "INCORRECT PASS REFER RESULT ~ ACCEPTED FAILURE RATE DEFINED BY THE ALGORITHMS. INCORRECT MEASUREMENTS LEADING TO ADDITIONAL PATIENT EXAMINATION." SEVERITY- NEGLIGIBLE (0). RISK LEVEL- MINOR (0). A RISK REVIEW IS NOT REQUIRED AS 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 HAS NO RECORD OF REPAIR SINCE INSTALL DATE IN (B)(6) 2019. INSTALL DATE: (B)(6) 2019. FURTHER INVESTIGATION TO BE CARRIED OUT.
FOLLOW UP REPORT 003 REF NATUS (B)(4). 04 NOV 22 - CUSTOMER CONTACTED- NO RESPONSE. 15 NOV 22 - CUSTOMER CONTACTED- NO RESPONSE. 10 JAN 23 - CUSTOMER CONTACTED - NO RESPONSE. COMPLAINT COULD NOT BE VERIFIED, THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS CASE HAS BEEN CLOSED OUT. NO RESPONSE FROM THE CUSTOMER AFTER VARIOUS ATTEMPTS. SHOULD THE CUSTOMER DECIDE TO SEND THE DEVICE AT A LATER STAGE A NEW CASE WILL BE OPENED BY NATUS.
INITIAL REPORT REF NATUS COMPLAINT#(B)(4). NATUS MEDICAL ACCUSCREEN ABR/DP TYPE 1077 - FALSE SCREENING RESULTS. E-MAIL RECEIVED THE (B)(6) 2022 FROM HEALTH CANADA REQUESTING ADDITIONAL INFORMATION AND STATING THE BELOW INFORMATION: THIS IS TO FOLLOW A REPORT SUBMITTED TO HEALTH CANADA INVOLVING THE ABOVE NOTED DEVICE REGARDING AN INCIDENT IN WHICH FALSE NEGATIVE SCREENING RESULTS WERE RECEIVED FROM TESTING AN INFANT WHO, UPON FURTHER INVESTIGATION, WAS IN FACT FOUND TO HAVE A HEARING IMPEDIMENT. THE REPORTER WISHES TO REMAIN ANONYMOUS AT THIS TIME. NO PART NO. OR LOT NUMBER PROVIDED. UDI NO. TO BE CONFIRMED. FURTHER INVESTIGATION TO BE CARRIED OUT.
PART 8-04-13932 NATUS MEDICAL ACCUSCREEN ABR/DP TYPE 1077 - FALSE SCREENING RESULTS. REPORTED INCIDENT IN WHICH FALSE NEGATIVE SCREENING RESULTS WERE RECEIVED FROM TESTING AN INFANT WHO, UPON FURTHER INVESTIGATION, WAS IN FACT FOUND TO HAVE A HEARING IMPEDIMENT.
PART 8-04-13932 NATUS MEDICAL ACCUSCREEN ABR/DP TYPE 1077 - FALSE SCREENING RESULTS. REPORTED INCIDENT IN WHICH FALSE NEGATIVE SCREENING RESULTS WERE RECEIVED FROM TESTING AN INFANT WHO, UPON FURTHER INVESTIGATION, WAS IN FACT FOUND TO HAVE A HEARING IMPEDIMENT.
PART 8-04-13932 NATUS MEDICAL ACCUSCREEN ABR/DP TYPE 1077 - FALSE SCREENING RESULTS. REPORTED INCIDENT IN WHICH FALSE NEGATIVE SCREENING RESULTS WERE RECEIVED FROM TESTING AN INFANT WHO, UPON FURTHER INVESTIGATION, WAS IN FACT FOUND TO HAVE A HEARING IMPEDIMENT.
NATUS MEDICAL ACCUSCREEN ABR/DP TYPE 1077 - FALSE SCREENING RESULTS. REPORTED INCIDENT IN WHICH FALSE NEGATIVE SCREENING RESULTS WERE RECEIVED FROM TESTING AN INFANT WHO, UPON FURTHER INVESTIGATION, WAS IN FACT FOUND TO HAVE A HEARING IMPEDIMENT. THE REPORTER WISHES TO REMAIN ANONYMOUS AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2480930 | ACCUSCREEN ABR/DP TYPE 1077 | ACCUSCREEN ABR/DP TYPE 1077 | GWJ | NATUS MEDICAL DENMARK APS | 8-04-13932 | 05713315003974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 YR | Unknown | Other |