MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED ABAER COLLECTION WITH DP

Model Number	580-ABBOX1002
Medical Device Problem Codes	Unable to Obtain Readings (1516); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Natus algo 5 hearing screener with oae and abr capabilities was not working.Several infants were not able to be screened before discharge as required.Referrals made for outpatient testing.Biomedical staff troubleshooting and working with company to get repaired.Procedure carried out at the time was newborn hearing screening as required before discharge.Customer states problem was device malfunction - the device did not do what it was supposed to do.
Additional Manufacturer Narrative
Initial report (b)(4).Related to report, (b)(4) that was received through fda's medsun program.On 13 sept 2023: additional infomation was received and the serial numbers that were provided were not for an algo 5 system.The customer provided information that the affected part was an ear probe.Confirmation required to confirm if related report, (b)(4) that was received through fda's medsun program, was actually for a biologic abear system and not an algo 5 system? a questionnaire has been sent to the customer.Further investigation to carried out.
Event or Problem Description
The affected part was not a algo 5 system.It was confirmed that the affected part was part 580-abbox1002 abaer collection with dp.Several infants were not able to be screened before discharge as required.Referrals made for outpatient testing.Biomedical staff troubleshooting and working with company to get repaired.Procedure carried out at the time was newborn hearing screening as required before discharge.Customer states problem was device malfunction - the device did not do what it was supposed to do.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint# (b)(4).Related to report, ((b)(4)) that was received through fda's medsun program.The affected part was not a algo 5 system.It was confirmed that the affected part was part 580-abbox1002 abaer collection with dp.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.Per (b)(4) hazard id.12, severity 6- negligible, risk level low.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.Per (b)(4), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Install date: jun-11-2021.Further investigation to carried out.
Event or Problem Description
The affected part was not a algo 5 system.It was confirmed that the affected part was part 580-abbox1002 abaer collection with dp.Several infants were not able to be screened before discharge as required.Referrals made for outpatient testing.Biomedical staff troubleshooting and working with company to get repaired.Procedure carried out at the time was newborn hearing screening as required before discharge.Customer states problem was device malfunction - the device did not do what it was supposed to do.
Additional Manufacturer Narrative
Follow up report 002 ref to natus complaint#(b)(4).Related to report, (3302260000-2023-8008) that was received through fda's medsun program.The service technician sent the questionnaire to the customer on multiple occasions on sep-13-2023, sep-28-2023, oct-17-2023 and nov-29-2023.No questionnaire or part was returned by the customer.Faillure confirmed: no closure rationale:complaint could not be verified, materials not returned for analysis.Complaint will be included in trending data for further review.

• Brand Name: ABAER COLLECTION WITH DP
• Common Device Name: ABAER COLLECTION WITH DP
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd. (xltek); 2568 bristol circle; oakville, ontario l6h 5s1, ; CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; dba excel-tech ltd.(xltek); 2568 bristol circle; oakville, ontarios, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 17753859
• Report Number: 9612330-2023-00033
• Device Sequence Number: 6768281
• Product Code: GWJ
• UDI-Device Identifier: 00382830000543
• UDI-Public: 382830000543
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K031009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2023

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: 580-ABBOX1002
• Device Catalogue Number: 580-ABBOX1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 09/05/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/12/2023; 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown