MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED QUANTUM BASE UNIT REFURB

Model Number	013926R
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4).The customer reported that when plugging in the usb cable between quantum base unit and computer, he see's a visible spark each time he connects it.Install date : (b)(6) 2019.Technical service requested the customer to return the quantum base unit , the computer and the cable for investigation.Parts returned 05 mar 2024.Further investigation to be carried out.
Event or Problem Description
Quantum base unit refurb - usb connection sparking.Plugged usb from pc to quantum base unit and connection sparks.No injuries.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).Per (b)(4) rev 69 xltek eeg/psg risk analysis spreadsheet hazard id 4.7 - electric shock - user cause - loss of ac power ground connection.Effects (harm) -range from clinically insignificant to death risk / benefit analysis - medium the hazards identified have been evaluated and found to be in compliance with a known standard.As noted in (b)(4), hazards that have been evaluated and found to be in compliance with known standards can be presumed to be consistent with an acceptable level of risk, yielding an acceptable risk / benefit to the patient or user.Risk outweighed by benefit of use of device.No related capas.The part was returned for evaluation and engineering noted the following on the investigation report: the quantum unit was plugged in with the usb cable from the computer, didn't notice any spark or electrical arcing.Tried at different usb connectors.Didn't notice any sparking.Root cause/probable root cause: didn't notice any sparking or electrical arcing.Usb has very low voltage it is has very low risk to the system or the user.
Event or Problem Description
Quantum base unit refurb - usb connection sparking.Plugged usb from pc to quantum base unit and connection sparks.No injuries.

• Brand Name: QUANTUM BASE UNIT REFURB
• Common Device Name: QUANTUM BASE UNIT REFURB
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, L6H 5 S1; CA L6H 5S1
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 18956213
• Report Number: 9612330-2024-00019
• Device Sequence Number: 14597356
• Product Code: GWQ
• UDI-Device Identifier: 00382830016315
• UDI-Public: 00382830016315
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: 013926R
• Device Catalogue Number: 013926R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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