MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED DELL OPTIPLEX 7440 ALL-IN-ONE (AIO) REFURB DESKTOP FOR XLTEK EEG/PSG

Model Number 020024R

Device Problem Crack (1135)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/31/2022

Event Type  malfunction  

Event Description

Dell optiplex 7440 all-in-one (aio) refurb desktop for xltek eeg/psg the customer reported to natus that pc serial number: (b)(4) was cracked on the left side of screen, and caused injury.Technical service followed up with the customer on how the damage was done, or what kind of injury there was, and requested more information and some pictures.

Manufacturer Narrative

Initial report ref to natus complaint# (b)(4).Technical service notified the customer that natus doesn't support windows 11 yet.All of the replacement systems will come with windows 10 installed.Qa requested that technical service obtain more information.Product return was not requested for the evaluation.The pictures of the damaged device were requested.Udi is unavailable.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.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.No complaint trends have been identified acceptable risk associated with the complaint as per line 5.100 in (b)(4) xltek eeg psg risk analysis spreadsheet, the 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.A search for service data that may have been relevant to this issue was conducted.No further information related to this issue was found.Further investigation to be carried out.

Event Description

Dell optiplex 7440 all-in-one (aio) refurb desktop for xltek eeg/psg the customer reported to natus that pc serial number: (b)(6) was cracked on the left side of screen, and caused injury.Technical service followed up with the customer on how the damage was done, or what kind of injury there was, and requested more information and some pictures.

Manufacturer Narrative

Folllow up report 001 ref to natus complaint# (b)(4).Product return was not requested for the evaluation.The pictures of the damaged device were requested.Quality requested technical service to obtain more additional adverse event questionaire, but no responses from the customer.Manufacturing date: not available since the customer did not response to the technical service follow up.Udi not applicable.Investigation result code (n/a :seattle|cause could not be determined closure rationale: 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.No death or serious injury, considered a customer inconvenience.

• Brand Name: DELL OPTIPLEX 7440 ALL-IN-ONE (AIO) REFURB DESKTOP FOR XLTEK EEG/PSG
• Type of Device: DELL OPTIPLEX 7440 ALL-IN-ONE (AIO) REFURB DESKTOP FOR XLTEK EEG/PSG
• 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: 14185208
• MDR Text Key: 299052047
• Report Number: 9612330-2022-00021
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 020024R
• Device Catalogue Number: 020024R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• 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