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

Catalog Number	826634
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: "the specialist received a call from neurosurgeon.He stated he has been caring for a 35 y/o s/p severe tbi patient and doesn¿t feel the icp values obtained from the icp express are accurate.The patient was admitted on (b)(6).And an icp sensor was placed (icp express + cerelink microsensor skull bolt kit).Upon admission and after implantation of the icp sensor, the icp value measured 4mmhg, he didn¿t feel the value was reflective of the patient¿s condition for she was unresponsive, ventilator dependent, and her ct showed multiple contusions, massive cerebral edema with slit ventricular syndrome.He changed the icp sensor but that didn¿t affect the value.He ended up doing serial ct scans in order to monitor the patient.He and the charge nurse were unaware of a 2nd icp express available to them, so they did not change out the monitor.The following day, the neurosurgeon called stating that now the icp values were labile and inaccurate for even without stimulus and over every couple of seconds the icp go from 14mmhg to 40mmhg, then down to 4mmhg.They were able to locate a 2nd icp express and switch it out.After changing monitors, the icp value (per neurosurgeon) was reliable.It was extremely elevated and did correlate with the ct findings." no patient injury was reported.
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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The microsensor (b)(6) was not returned for evaluation after three good faith attempts (gfes) were made.Serial number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause 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.
Event or Problem Description
N/a.

• 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: 17738084
• Report Number: 3014334038-2023-00154
• Device Sequence Number: 17779904
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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 Catalogue Number: 826634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 11/22/2023
• Date Device Manufactured: 04/28/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CERELINK MICROSENSOR SKULL BOLT
• Patient Age: 35 YR
• Patient Sex: Unknown