MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NICVIEW

Model Number ARM-002

Device Problems Break (1069); Crack (1135)

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

Event Date 09/03/2022

Event Type  malfunction  

Event Description

Part arm-002 - long (39.5" = 100cm) assy.- customer reported the camera mount and arm fell off the wall.The follow up e-mail mentioned that the camera mount almost fell on a patient but the nurse caught it.No injuries.

Manufacturer Narrative

Initial report (ref natus complaint# (b)(4)).Per hazard id b2 of (b)(4)- risk analysis for nicview, the risk is considered low.Severity 3 - 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.Technical support sent the customer a ae questionnaire to obtain additional information about the incident.Affected product has been requested to be returned for evaluation.

Event Description

Part arm-002 - long (39.5" = 100cm) assy.- customer reported the camera mount and arm fell off the wall.The follow up e-mail mentioned that the camera mount almost fell on a patient but the nurse caught it.No injuries.

Manufacturer Narrative

Follow up report 001 (ref natus complaint# (b)(4) ).Initial investigation by engineering confirmed this is the same issue seen on capa004584 - customer resolution consists of natus providing retrofit kits for each of the affected clamps.The retrofit kit consists of one screw for each nicview clamp and will include installation instructions.Installation consists of removing the small center screw from the arm-mounting clamp and replacing it with a shorter screw.In addition customers are provided with a mounting pin if required to resolve the broken arm.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 failure confirmed: yes.Investigation result code: neuro sbu|loss of mechanical integrity.

• Brand Name: NICVIEW
• Type of Device: NICVIEW
• 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: 15437442
• MDR Text Key: 306321962
• Report Number: 9612330-2022-00045
• Device Sequence Number: 1
• Product Code: IOY
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARM-002
• Device Catalogue Number: ARM-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2022
• 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