MAUDE Adverse Event Report: RAYNHAM CERELINK ICP PROBE 1L M BOLT; ICP MICRSOSENSORS - CERELINK

Model Number	826851
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a patient had a bolt placed with good waveform and icp value.25-30 minutes later, the surgeon received a call that the icp reading was -32.They changed the cables and showed a message of failed sensor.The monitor read occasionally then worked again.It stopped working again at 11pm.The surgeon decided to wait until morning but still did not work.They took the patient back to the or to have it replaced.A second sensor would not zero with the monitor which stated failed sensor and it was replaced with another sensor.
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
The cerelink icp probe was returned for evaluation.Dhr review: review of the history device records for the product code 826851 with lot 4336637 conformed to the specifications when released to stock failure analysis: the issue of the complaint was not confirmed.No visible damage to the millar sensor or connector; catheter has several kinks.Icp express passed with reading 484.The device passed electronic, noise, linearity/hysteresis, and signal drift tests.The root cause of the issue reported by customer could not be determined as the device worked correctly.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP PROBE 1L M BOLT
• Common Device Name: ICP MICRSOSENSORS - 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: 12918545
• Report Number: 3013886523-2021-00537
• Device Sequence Number: 4983234
• Product Code: GWM
• UDI-Device Identifier: 10886704075431
• UDI-Public: (01)10886704075431(17)211231(10)4336637
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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 Expiration Date: 12/31/2021
• Device Model Number: 826851
• Device Catalogue Number: 826851
• Device Lot Number: 4336637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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