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	06/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report (b)(4) the customer provided a picture of the wiring.The customer was instructed to cease the use of the algo and advised that a replacement column with wiring will be sent.A mera technician will be dispatched onsite to install it.05-june-2023: the customer was shipped a replacement algo 5 cart column with wiring.06-june-2023: created tpi-3519 for engineering investigation.Per (b)(4) algo 5 risk analysis, hazard id - 2.1, severity - 12, risk is considered 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.This complaint does not identify a deficiency in the product design and therefore a capa is not required.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.Further investigation to be carried out.
Event or Problem Description
Algo 5 cart column with wiring -customer reported the algo 5 cart column with wiring had presented intermittent loss of power, and the system would not turn on.The device was inspected and it was noted the power cords under the base has torn insulation of the wiring.The customer noted while inspecting the wiring she experienced a shock from the algo.It was noted that the wire appeared to have been rubbing against one of the wheels which created the problem.
Event or Problem Description
Algo 5 cart column with wiring -customer reported the algo 5 cart column with wiring had presented intermittent loss of power, and the system would not turn on.The device was inspected and it was noted the power cords under the base has torn insulation of the wiring.The customer noted while inspecting the wiring she experienced a shock from the algo.It was noted that the wire appeared to have been rubbing against one of the wheels which created the problem.
Additional Manufacturer Narrative
Follow up report 001 complaint#(b)(4).The customer returned the completed adverse event questionnaire.Per the customer, they received a shock from the electrical cable under the unit.They were trying to troubleshoot the machine to find out why it was not powering on and did not see the exposed wire before placing their hand down on the wire.No medical intervention was needed.Mera technician was onsite.Upon inspection the mera technician found that two of the power cables showed damage due to possible rubbing during transport of the unit.The mera technician installed the replacement column assembly and installed several wire ties and routed the cables away from any possible contact with the wheels of the unit.The system was tested after, and no issues were noted.Technical service are following up with the customer and requested that the product be returned.
Event or Problem Description
Algo 5 cart column with wiring -customer reported the algo 5 cart column with wiring had presented intermittent loss of power, and the system would not turn on.The device was inspected and it was noted the power cords under the base has torn insulation of the wiring.The customer noted while inspecting the wiring she experienced a shock from the algo.It was noted that the wire appeared to have been rubbing against one of the wheels which created the problem.
Additional Manufacturer Narrative
Follow up report 002, ref compalint#(b)(4).Per the customer, they received a shock from the electrical cable under the unit.They were trying to troubleshoot the machine to find out why it was not powering on and did not see the exposed wire before placing their hand down on the wire.No medical intervention was needed.Ship date of affected product was: june 02, 2020.This complaint does not identify a deficiency in the product design and therefore a capa is not required.Per doc-037739 algo 5 risk analysis, hazard id - 2.1, severity 13 - major, risk is considered 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.Faillure confirmed: yes.Investigation result code: neuro sbu|damaged power cord.Closure rationale:complaint verified, being tracked as a trend.Complaint will be included in trending data for further review.

• 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: gráinne walsh ; dba excel-tech ltd.(xltek); 2568 bristol circle; oakville, ontarios, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 17113756
• Report Number: 9612330-2023-00011
• Device Sequence Number: 20450234
• Product Code: GWJ
• UDI-Device Identifier: 00382830043939
• UDI-Public: 00382830043939
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 06/02/2023; 06/02/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 08/03/2023; 08/23/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose