MAUDE Adverse Event Report: RAYNHAM ICP EXPRESS; ICP EXPRESS - MONITOR

Model Number	82-6634
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 2 reports linked to mfg report numbers: (b)(4).A facility reported a cerelink microsensor (id 826851) was placed on (b)(6) 2022.The initial reading was 3.The icp express monitor was working correctly and intracranial pressure (icp) was being displayed.When the icp express was plugged in to the bedside monitor, the bedside was zeroed correctly and was matching the correct icp.In the morning of (b)(6) 2022, the icp express began reading a negative icp.The waveform looked great, but no troubleshooting was able to fix the negative reading.Therefore, the surgeon decided to plant and replace the sensor on (b)(6) 2022.A new cerelink microsensor was implanted and is reading normal icp.The icp express monitor was working correctly clinical questionnaire provided: hospital name: (b)(6), hospital location: (b)(6).Time/date of failure: 5 am (b)(6) 2022, description of the failure: reading negative icp.Sensor information a.Kit used: metal bolt (826851), b.Serial number: (b)(4).D.Implant location: parenchymal.E.Hospital location of implant: icu cerelink monitor serial number: (b)(4), did the failure occur during patient movement? (i.E.Reposition, transport, out of bed for bathroom, ambulate, chair, etc.) no a.Was a movement assistance device used? if yes, please specify.N/a b.Amount of time between patient movement and failure event.N/a c.Was the microsensor disconnected from the cerelink monitor during each phase of transport? no d.Did the patient receive an mri or ct scan before the failure occurred? mri what was the mean icp before the ¿event¿? icp value: 2 what was the icp waveform quality before the ¿event¿? normal what is the current mean icp? -9 what is the icp waveform quality after the ¿event¿? normal when the failure occurred, was the icp express monitor plugged into the wall? yes when the failure occurred, was the icp express monitor connected to a patient monitor? yes a.If yes, provide patient monitor make & model - make: icp express / model: 82-6634 when the failure occurred, where was the icp express monitor positioned? iv pole other: list all devices being used close to the icp express monitor: patient monitor other devices implanted in the head? (shunt, evd, subdural drain).If yes, specify: none were bipolar or monopolar forceps used while the sensor was plugged in? no provide a description of any unusual events or issues that occurred during the implantation or during the patient care : n/a describe the quality of the insertion: no issues.Good insertion take a picture of the explanted sensor tip or provide a detailed description (blood coagulations, physical deformity, residues, etc.): no residue that can be seen.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h4, h6, h10.The icp express monitor is not available for return as per customer.Therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: ICP EXPRESS
• Common Device Name: ICP EXPRESS - MONITOR
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15512155
• Report Number: 3014334038-2022-00222
• Device Sequence Number: 14763058
• Product Code: GWM
• UDI-Device Identifier: 10886704042341
• UDI-Public: 10886704042341
• Combination Product (Y/N): N
• PMA/510(K) Number: K945585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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: Health Professional
• Device Model Number: 82-6634
• Device Catalogue Number: 826634
• Device Lot Number: 9485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/21/2022
• Date Device Manufactured: 11/14/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown