MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED ALGO 5 CART COLUMN WITH WIRING

Model Number	004691
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported one of the power cords in the column of the algo 5 newborn hearing screener had damaged insulation and provided photo.There was no patient involvement and no injury reported.
Additional Manufacturer Narrative
Initial report ref to natus complaint# (b)(4).Customer stated that the warning prompted a few times during a hearing screen, so she was unable to screen patient.She noted that she confirmed that all cords were secured.Upon further inspection, it was discovered that one of the power cords in column had damaged insulation.Also, the lock ring on the dc connector to the panel pc was not fully seated.It was advised to stop using the device and have a new cart column installed.Technical service shipped to customer one warranty replacement algo 5 cart column with wiring.Natus technical service manager confirmed the cable showing the damage is coming from the cart column.As part of this failure, the mera technician will also replace the dsp as the power cable used is associated with the dsp.There are no capa's related to this issue and this complaint does not identify a deficiency in the product design and therefore a capa is not required.Doc-(b)(4) algo 5 risk analysis hazard i.D.4.0 severity 6 is moderate and the risk rating 6 is low.Per qms-004442 complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.No complaint trends have been identified.Further investigation to be carried out.
Event or Problem Description
Customer reported one of the power cords in the column of the algo 5 newborn hearing screener had damaged insulation and provided photo.There was no patient involvement and no injury reported.
Additional Manufacturer Narrative
Follow up report ref to natus complaint# (b)(4).The field service technician on site completed repair.Field service reported replaced a column and dsp per techical support.Complete work and test.System boots and works properly.No return parts.Additional information received from field service technician, the damaged power cord appeared to have possibly rubbed against one of the cart wheels, over time had worn through the insulation.He replaced the cart column and dsp and had the staff run the equipment checks, which passed.Customer confirmed all was fixed regarding the issue.This failure was confirmed.Investigation result code: seattle|wear and tear.Closure rationale: complaint verified, resolved on-site and no further action necessary.Low safety risk of harm, individual complaint related to issue stated.Complaint will be included in trending data for further review and investigation if needed.

• Brand Name: ALGO 5 CART COLUMN WITH WIRING
• Common Device Name: ALGO 5 CART COLUMN WITH WIRING
• 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: walsh ; dba excel-tech ltd. (xltek); 2568 bristol circle; oakville, ontario l6h 5s1, ; CA
• MDR Report Key: 13786749
• Report Number: 9612330-2022-00014
• Device Sequence Number: 19789315
• Product Code: GWJ
• UDI-Device Identifier: 00382830043939
• UDI-Public: 00382830043939
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

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: 004691
• Device Catalogue Number: 004691
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 05/04/2022
• 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