MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED DELL LATITUDE 5510 LAPTOP EEG/SLEEP SYSTEM

Model Number 033965

Device Problem Overheating of Device (1437)

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

Event Date 06/07/2022

Event Type  malfunction  

Event Description

Dell latitude 5510 laptop eeg/sleep system: overheating / hot to the touch / making sizzling noise while charger is plugged in.No patient was involved.No injuries.

Manufacturer Narrative

Initial report ref natus complaint# (b)(4).Udi number not applicable.Customer reported their laptop was overheating.Service technician asked customer for additional information, if fan failed or if laptop shut down or if they noticed any environmental concerns.Customer called back and explained that the laptop was hot to the touch and making a sizzling noise while charger is plugged in.Per hazard id (b)(6) of (b)(4): eeg/psg risk analysis, the risk is considered low.Installed: (b)(6) 2022.Laptop was not placed on a heated surface.Device is being returned to natus for evaluation.

Manufacturer Narrative

Follow up report 001 ref natus complaint# (b)(4).Customer responded to ae questionnaire: - no patient was involved.- cannot use laptop as soon as they start it starts heating up.- no medical intervention required - no injury to patient or user.- no other natus devices in use.- no non-natus devies were in use.- laptop was not placed on a heated surface.- no photos available of any visible damage.Tpi-2648 created to document engineering investigation results.The results were as follows: laptop did not generate any excessive heat was running fine during this test.Run the stress test of cpu, ram and disk utilization of 100% for more than 3 hours and still laptop was running at 62oc which is normal or just above normal (considering cpu was running at max capacity for more than 3 hours).Laptop passed all the stress tests and issue could not be duplicated during testing.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 qms-004442, complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Service repair investigations will be conducted during the repair process and trend data will be reviewed per qms-004442.Installed: 12-apr-2022.Faillure confirmed: no.Investigation result code: neuro sbu|no issues noted.Closure rationale :complaint could not be verified, monitor for future occurrence.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.

Event Description

Dell latitude 5510 laptop eeg/sleep system - overheating / hot to the touch / making sizzling noise while charger is plugged in.No patient was involved.No injuries.

• Brand Name: DELL LATITUDE 5510 LAPTOP EEG/SLEEP SYSTEM
• Type of Device: DELL LATITUDE 5510 LAPTOP EEG/SLEEP SYSTEM
• 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 ltd.; 2568 bristol circle; oakville, ontarios, l6h 5s1, ; CA
• MDR Report Key: 14827312
• MDR Text Key: 294790761
• Report Number: 9612330-2022-00039
• Device Sequence Number: 1
• Product Code: LNX
• 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
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 033965
• Device Catalogue Number: 033965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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