MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED MICRO VENTRICULAR BOLT PRESSURE MONITORING KIT; INTRCRANIAL PRESSURE MONITORING DEVICE

Model Number	110-4HM
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
"the 1104hm was placed and initial reading correlated.When surgeon rounded this morning icp reading was off by 20.Surgeon discontinued use of the cam02 and catheter monitoring and resumed with a transducer and manual icp monitoring." there was no patient injury or death alleged.The device was in contact with the patient.The customer reported no revision or medical intervention required as a result of this event.This was not an out-of-box failure.Additional information has been requested.See related 2023988-2017-00503.
Additional Manufacturer Narrative
E-mail received 13 dec 2017 in request for additional information: "was any medical intervention required? no"."operator of device or, who was using it when the malfunction or injury was observed? physician"."date catheter was placed, if applicable: unknown"."date catheter was removed, if applicable: unknown"."was a user facility report submitted to fda? no".Natus has completed their internal investigation on 04 dec 2017.The investigation included: review of complaints from user facility, capa review, complaint history review/trend analysis.There were (b)(4) other 110-4xxx complaints from (b)(6) medical center since oct-2015.No similar complaints were confirmed.A review of capas within the past 12 months specific to this customer's complaint under investigation found no capa related to this reported catheter complaint.Complaint history, model 110-4xxx, from nov-2015 through 27-nov-2017 reviewed; there were (b)(4) other complaints that issued with complaint code (b)(4), and one of them was confirmed.The number of confirmed reports (b)(4) divided by the number of units sold model 110-4xxx, ((b)(4)), nov-2015 through oct-2017 and multiplied by 100 results in a failure rate percentage (b)(4).The complaint could not be confirmed as the customer has not returned the device for evaluation.However, when evaluating a related device (cam02) from this incident (ref.Mdr 2023988-2017-00503), a defective accessory cable was discovered (ref.Mdr 2023988-2017-00513 for the camcabl).

• Brand Name: MICRO VENTRICULAR BOLT PRESSURE MONITORING KIT
• Common Device Name: INTRCRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; 5955 pacific center blvd.; san diego CA 92121
• MDR Report Key: 7037346
• Report Number: 2023988-2017-00507
• Device Sequence Number: 11185200
• Product Code: GWM
• UDI-Device Identifier: 10381780258049
• UDI-Public: 10381780258049
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K914735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 110-4HM
• Device Catalogue Number: 110-4HM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/15/2017
• Patient Sequence Number: 1