MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED OBM DAB (DIGITAL ACQUISITION BOX)

Model Number OBM00002

Device Problem No Display/Image (1183)

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

Event Date 01/16/2023

Event Type  malfunction  

Manufacturer Narrative

Initial report ref natus complaint (b)(4).Install date: february 13, 2014.Per the distributor service request form, the problem was identified during a patient procedure.The procedure was completed but was delayed.Further investigation to be carried out.

Event Description

Part obm00002 obm dab (digital acquisition box) - natus olympic brainz monitor was connected to a patient and functioning.Suddenly the monitor stopped working, started beeping, and the monitoring stopped.Unable to resume monitoring after all connections were checked, monitor turned off and back on.No patient or user harmed.

Manufacturer Narrative

Follow up report 001 ref natus complaint #(b)(4).The obm was evaluated.It was found that the obm did not function.The dut was plugged into the obm 401 panel pc, and the pc did not recognize the dut being plugged in and when running a patient test there would be a warning message saying there is no dap installed.Different ports were tried on the pc and also gave the dap a wire wiggle test with the same non-functioning results.Faillure confirmed: yes.Investigation result code :neuro sbu|connection issue.Complaint verified, being tracked as a trend.Complaint will be included in trending data for further review.Per doc(b)(4) olympic brainz monitor risk analysis, hazard id - 5.25, 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.

Event Description

Part obm00002 obm dab (digital acquisition box): natus olympic brainz monitor was connected to a patient and functioning.Suddenly the monitor stopped working, started beeping, and the monitoring stopped.Unable to resume monitoring after all connections were checked, monitor turned off and back on.No patient or user harmed.

Event Description

Part obm00002 obm dab (digital acquisition box) - natus olympic brainz monitor was connected to a patient and functioning.Suddenly the monitor stopped working, started beeping, and the monitoring stopped.Unable to resume monitoring after all connections were checked, monitor turned off and back on.No patient or user harmed.

Manufacturer Narrative

Follow up report 002 ref natus complaint#(b)(4).The repair technician states that he opened the obm digital aquisition box and found that the wires from the harness, that has the universal serial bus (usb) plug side, broke off the solder joint on the pcb board and the potting compound that would hold the wires in place failed.This failure, without a doubt was caused by an excessive pulling on the cable end of the digital aquisition box.

• Brand Name: OBM DAB (DIGITAL ACQUISITION BOX)
• Type of Device: OBM DAB (DIGITAL ACQUISITION BOX)
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, L6H 5 S1; CA L6H 5S1
• 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 5-S1 ; CA L6H 5S1
• MDR Report Key: 16873181
• MDR Text Key: 314725385
• Report Number: 9612330-2023-00003
• Device Sequence Number: 1
• Product Code: OMC
• UDI-Device Identifier: 00382830010825
• UDI-Public: 00382830010825
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K093949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OBM00002
• Device Catalogue Number: OBM00002
• Device Lot Number: 000688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1