MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED ISOLATION TRANSFORMER - 110V ERGOJUST CART

Model Number ISO-NA-EJ

Device Problems Thermal Decomposition of Device (1071); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

Medical grade ups with isolation - 110v ergojust cart.The technician plugged in the power cord and smelt burning.Immediately unplugged and put out of service.No patient involved.No injuries.

Manufacturer Narrative

Initial report (ref complaint (b)(4)).The customer reported power plug design is bad and keeps getting burned.Customer reported found note on machine xlicumon09 s/n (b)(4)(computer) that isolation transformer sparked and smoked at plug.Customer reported no one was injured.Technical service requested customer return device to natus.Request photo of rating plate of device with manufacture date and part number.Did device have 10 foot cable or 15-foot cable? per questionnaire: date of event (b)(6) 2022.Device: ametek powervar 3.0, s/n (b)(4).Technician plugged in power cord, smelt burning, immediately unplugged and put out of service.A video eeg was going to be performed.Equipment was not on patient.Procedure did not take place.Tpi-2335 created for engineering investigation.Affected part requested to be returned for investigation.Per doc (b)(4) xltek eeg psg risk analysis, hazard i.D.Line 2.1 failure of amplifier power supply/ transformer, the severity score 11 is moderate.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.

Event Description

Isolation transformer - 110v ergojust cart.The technician plugged in the power cord and smelt burning.Immediately unplugged and put out of service.No patient involved.No injuries.

Manufacturer Narrative

Follow up report 001 ref complaint (b)(4)).(b)(6) 2022 engineering shipped medical grade ups with isolation s/n (b)(4) to powervar for evaluation.Powervar failure analysis report which was closed on the 12 april 2022 noted the following details: they disassembled and inspected both nema 5-15 connectors.The main damages to the internal elements resulted in power cord shortages are: exposed wires with melted insulation inside and outside of the connector bodies.Ground and neutral wires forcefully detached from points of termination with broken pieces of strain still inside the terminals.The nature of the damages allows to conclude that the cause of shortages was an overly excessive pull-out force applied to power cords repetitively for an extended time period.No corrective actions identified due to the nature of the damages.Closure rationale:complaint verified, being tracked as a trend.Based on evaluation of this complaint there is no safety risk of harm, individual complaint related to issue stated.Complaint will be included in trending data for further review and investigation if needed.

Manufacturer Narrative

Follow up report (ref complaint (b)(4)).Customer reported fourth isolation transformer same issue.No one was injured.Field service technician.On-site: customer had extra isolation transformers.Could not associate isolation transformer with particular cart.Customer took first two isolation transformers with burnt plugs and replaced with spares.Returned those two and would provide tracking numbers.Isolation transforms have ten-foot cable.Two isolation transformers with burnt plugs at site.Plugs had a burn hole where ac plug clamp squeezed cable to secure it.Field service installed four ups units on four carts with isolation transformer box.Customer could not determine which cart originally had a burnt plug.The customer provided pictures of the affected part.21 mar 2022 engineering shipped medical grade ups with isolation s/n (b)(4) to powervar for evaluation.11 apr 2022 engineering confirmed correct part for this case/related cases is (b)(4).

Event Description

Isolation transformer - 110v ergojust cart.The technician plugged in the power cord and smelt burning.Immediately unplugged and put out of service.No patient involved.No injuries.

• Brand Name: ISOLATION TRANSFORMER - 110V ERGOJUST CART
• Type of Device: ISOLATION TRANSFORMER - 110V ERGOJUST CART
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, l6h 5s1, ; CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; dba excel-tech; 2568 bristol circle; oakville, ontario, l6h 5s1 ; CA
• MDR Report Key: 13356792
• MDR Text Key: 286643875
• Report Number: 9612330-2022-00005
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ISO-NA-EJ
• Device Catalogue Number: ISO-NA-EJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1