MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED DBA INTEGRA NEUROSCIENC INTRACRANIAL PRESSURE-TEMPERATURE MONITORING KIT; INTRACRANIAL PRESSURE MONITORING DEVICE

Model Number	110-4BT
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Information documented on report form received 25 oct 2017: "has a short - had to be turned to get number to come up" for what type of procedure was product or device used? "pressure monitoring of brain" did product malfunction? "yes" did malfunction result in patient or user injury? "no" did it result in death? "no" was product found unacceptable or did it fail prior to first clinical use? "yes" additional information received 14 nov 2017 from integra: device in contact with patient? "yes" revision/medical intervention required? "no" "replacement of fiber optic" patient prepped for surgery? "no just place of probe at bedside" patient information (age and gender) "male (b)(6)" delay in surgery due to late receipt of product? "no" delay in surgery due to product problem "no" "delay in monitoring and unable to get correct opening pressures" was it an out of box failure: a.Date product purchased "do not have exact date but within last month frequently used item" b.Did the product fail during commissioning, decontamination or setup procedures prior to first clinical use? "failed after placement in brain" complaint is for model 110-4bt, however, the l/n of the claimed malfunctioning device was not specifically identified (presumable one of two l/ns listed on complaint form).The site has requested an rma to return five devices, one of which may be the compliant device.Additional follow-up information regarding will be requested.
Additional Manufacturer Narrative
Added 22 jan 2018: natus has completed thier internal investigation on 01 dec 2017 for this non-returning device.The investigation included: methods: review of device history records, review of complaints history/complaint rate, review of past capas/capa determination.Results: the device history record for the catheter was reviewed, there were no anomalies observed during the manufacturing, packaging or inspection of the device or accessories while in process.Additionally, because the product was not returned for evaluation, no root cause could be established for the failure mode described in the customer complaint.There was no other 110-4xxx complaint that was issued for (b)(6) since oct-2015.There were fourteen (14) confirmed complaints during may-2015 through apr-2017 under complaint code (b)(4).(b)(4).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.Capa # issued: n/a the customer's complaint "has a short - had to be turned to get number to come up" could not be confirmed as the customer has not returned the device for evaluation.This complaint is now demed closed.
Event or Problem Description
The initial reporter submitted the following 13 dec 2017 in response to an e-mail requesting further event details: "was there any injury to the patient? no" "was any medical intervention required? no" "was there a delay in surgery caused by the product issue? no" "patient: age (b)(6)" "gender: male" "weight (b)(6)" "date catheter was placed, if applicable: (b)(6) 2017" "date the catheter was removed, if applicable: (b)(6) 2017" "was a user facility report submitted to fda? no" upon request for further details from the initial reporter, the following was received 17 jan 2018: "operator of device" or, who was using it when the malfunction or injury was observed? (by profession such as "physician", med tech, etc.) physician snd nurse".

• Brand Name: INTRACRANIAL PRESSURE-TEMPERATURE MONITORING KIT
• Common Device Name: INTRACRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED DBA INTEGRA NEUROSCIENC; 5955 pacific center blvd.; san diego CA 92121
• MDR Report Key: 7038050
• Report Number: 2023988-2017-00506
• Device Sequence Number: 19151356
• Product Code: GWM
• UDI-Device Identifier: 10381780023630
• UDI-Public: 10381780023630
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K102875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• 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: 110-4BT
• Device Catalogue Number: 110-4BT
• Device Lot Number: 111ERX311927, 111ERX307920
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 01/22/2018
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 98