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

Model Number	826634
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 1 of 3 reports linked to mfg report numbers: 3014334038-2022-00209, 3013886523-2022-00433.A facility reported a microsensor (id 826851) was implanted on (b)(6) 2022.In the morning of (b)(6) 2022 the patient was disconnected from icp express monitor (id 826634) and transported to a "ct".Upon arrival back to the pediatric "icu" from "ct" the microsensor was reconnected to the icp express and message ¿sensor not detected¿ appeared.Troubleshooting was completed (changed monitors) and the same message appeared.Therefore, the microsensor was removed and replaced on (b)(6) 2022 and the appropriate intracranial pressure value was received.The two monitors are still working fine after a new microsensor was implanted.
Additional Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.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
The icp express monitor (id 826634) 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.
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: 15462092
• Report Number: 3014334038-2022-00208
• Device Sequence Number: 17211833
• Product Code: GWM
• UDI-Device Identifier: 10381780520443
• UDI-Public: 10381780520443
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 826634
• Device Catalogue Number: 826634
• 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: 09/03/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 09/21/2022
• Supplement Report FDA Received Date: 10/21/2022
• Date Device Manufactured: 06/08/2020
• 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