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

Model Number 826820

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2022

Event Type  malfunction  

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 Description

This is 1 of 2 reports linked to mfg report number: a facility reported a cerelink monitor having difficulties synching in to the bedside with negative icp and no waveform.The patient was still hooked up to the cerelink with a negative number at the date of the report.

Manufacturer Narrative

Additional information received: please provide product id and lot/serial number of the sensor.If unknown, please specify if the sensor is cerelink or directlink - serial number unknown, but cerelink sensor what cable was used, please provide product id and lot/serial number? the cable that came with the cerelink what was the initial reading? normal readings under 10mmhg after the negative readings, the cables were switched? there were no cables to switch, as the other monitors had been removed from the hospital.The product was explanted? if yes, provide date yes, the following day.Was the sensor replaced? unknown.Patient current status? unknown.

Manufacturer Narrative

The cerelink monitor (826820)  was not returned for evaluation after three good faith attempts (gfes) were made.Lot 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.A corrective and preventative action (capa) has been opened to further investigate failures for the cerelink product family.Additional root cause will be investigated under the capa.

• Brand Name: CERELINK ICP MONITOR
• Type of Device: ICP MONITOR-CERELINK
• 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: 15710714
• MDR Text Key: 306903635
• Report Number: 3014334038-2022-00244
• Device Sequence Number: 1
• Product Code: GWM
• UDI-Device Identifier: 10381780533788
• UDI-Public: 10381780533788
• Combination Product (y/n): N
• PMA/PMN Number: K183406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 826820
• Device Catalogue Number: 826820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1