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

Model Number	826820
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
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
This is 2 of 2 reports.Other mfg report no.: 3013886523-2022-00145.It was reported that a brand new cerelink basic kit was used with demonstration monitor.It worked for a few demonstrations but noticed that the monitor had slowly started to increase in icp to the 40¿s.The sensor was just sitting on the table, with no pressure on it at all.Then, it started to drop and go negative, until cable/sensor failure was noted.Everything was unplugged, waited over 20 minutes and when plugged back in the sensor, the cable/sensor failure again prompted.Next, they disconnected everything, plugged in the sensor and tried to zero it again.It gave the red light, stating they could not zero it.
Additional Manufacturer Narrative
Cerelink icp monitor was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer 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 action has been opened to investigate the failure mode "out of range reading".
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP MONITOR
• Common Device Name: 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: 14101940
• Report Number: 3014334038-2022-00070
• Device Sequence Number: 20390696
• Product Code: GWM
• UDI-Device Identifier: 10886704075622
• UDI-Public: 10886704075622
• Combination Product (Y/N): N
• PMA/510(K) Number: K183406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: 826820
• Device Catalogue Number: 826820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 07/13/2022
• Date Device Manufactured: 06/18/2019
• 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