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

Model Number	004691
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Algo 5 cart column with wiring - when installing the panel pc technical found that he wiggles the cord going into the panel pc power supply it creates somewhat of a spark.No injuries.
Additional Manufacturer Narrative
Initial report complaint# (b)(4).The customer was shipped a replacement algo 5 cart column with wiring.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) algo 5 risk analysis hazard id.2.4, severity 13-negligible, risk level medium.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.(b)(4) was suspected to be related to this case.Tracking number confirms that the allegedly defective algo 5 cart column was received for investigation at the bothell facility.Awaiting investigation results.
Additional Manufacturer Narrative
Follow up report 001 complaint# (b)(4).The affected part was returned for evaluation.Failure confirmed: yes.Investigation result code: seattle: wear and tear.Closure rationale: complaint verified, being tracked as a trend.Complaint will be included in trending data for further review.
Event or Problem Description
Algo 5 cart column with wiring - when installing the panel pc technical found that he wiggles the cord going into the panel pc power supply it creates somewhat of a spark.No injuries.

• 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: 16502088
• Report Number: 9612330-2023-00002
• Device Sequence Number: 15017493
• Product Code: GWJ
• UDI-Device Identifier: 00382830043939
• UDI-Public: 00382830043939
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K073665
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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: 004691
• Device Catalogue Number: 004691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/03/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose