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

Model Number OBM00002

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

Initial report ref natus complaint (b)(4) the device was used with a patient for approximately 19 hours.The customer was given an adverse event questionnaire to complete and return for natus's investigation.The customer stated they will work with the clinical handler to review and provide answers.The customer was shipped 1 obm dab (digital acquisition box), serial number:(b)(6) for exchange.Risk file review: doc-013950 rev 11 olympic brainz monitor(obm) risk analysis spreadsheet (ras) hazard id - 6.13 - inadequate packaging / shipping specifications effects (harm): data loss.Delayed diagnosis.The hazards identified have been reduced as far as possible, and the residual risk for these hazards are categorized as having an rba rating of low due to the nature of the hazard.Hazards have associated warnings disclosed in the ifu.Risk outweighed by benefit of use of device.Further investigation to be carried out.

Event Description

Part obm00002 obm dab (digital acquisition box) mislabeled.The customer reported experiencing issues with their obm (olympic brains monitor) having the electrode placement sticker on backwards, resulting in the electrodes being applied incorrectly.

Manufacturer Narrative

Follow up report 002 ref natus complaint#(b)(4) update to risk file review: per doc-013950 rev 12 olympic brainz monitor(obm) risk analysis spreadsheet (ras) hazard id - 5.39 - device label depicting electrode connection is attached in the wrong orientation.User misinterprets device label and connects electrodes so that the left and right channels are swaped effects (harm): wrong diagnosis with no clinical effects.The hazards identified have rba rating of negligible and are deemed broadly acceptable.These risks have been reviewed to determine if any further control measures may be implemented so as to further reduce the risk as far as possible.Risk outweighed by benefit of use of device.Device was returned 08 february 2024 13 february 2024 sustaining engineer provided evaluation details - operator error leading to label applied incorrectly at contract manufacturer creation.Scar-000067 created to document issue with the supplier.Work instructions qms-004738 shows correct orientation for applying label to the product.There is no additional documented downstream verification for correct label application.Label and cutout where label is to be applied is symmetrical in shape.This allows the label to fit properly into the cutout in both the correct and incorrect orientations.Failure confirmed: yes investigation result code: neuro sbu|user error.

Event Description

Part obm00002 obm dab (digital acquisition box) mislabeled.The customer reported experiencing issues with their obm (olympic brains monitor) having the electrode placement sticker on backwards, resulting in the electrodes being applied incorrectly.

Manufacturer Narrative

Follow up report ref natus complaint# (b)(4).Jan 10, 2024 -technical service reached out to the customer in a second attempt to get them to complete the questionnaire and to return the defective device.Jan 15, 2024: customer reached out and reported the device was in fact not used with a patient.Customer stated they will not fill out and return their form.Customer confirmed they will return the data acquistion box.Feb 02, 2024 - awaiting return of the affected device for evaluation.

Event Description

Part obm00002 obm dab (digital acquisition box) mislabeled.The customer reported experiencing issues with their obm (olympic brains monitor) having the electrode placement sticker on backwards, resulting in the electrodes being applied incorrectly.

• 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: 18490690
• MDR Text Key: 333200828
• Report Number: 9612330-2024-00003
• 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: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other