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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP MONITOR; ICP MONITOR-CERELINK

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INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP MONITOR; ICP MONITOR-CERELINK Back to Search Results
Model Number 826820
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/09/2022
Event Type  Injury  
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
1 of 3 reports.Other mfg report nunbers: 3013886523-2022-00344, 3013886523-2022-00345.A facility reported a patient had been monitored for 5 days and there were no problems.The pressure was really high and they decided to perform a decompressive surgery.They zeroed the new sensor (successfully inserted it in the parenchyma) and after that the value of the icp moved from +5mmhg to -50mmhg.Immediately afterwards there was the alarm "change cable or sensor".They changed 2 sensors and 2 cables, they changed also the cerelink monitor but it still gave the same alarm.At the end they switched the cerelink off and they brought patient to the icu.After 3 hours, they switched it on and it started working correctly with icp at +14mmhg.The event led to a significant surgical delay (2 to 4 hours).
 
Manufacturer Narrative
Cerelink monitor was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the cerelink unit was inspected: no anomalies were observed.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.Additional information received: the patient is doing physical therapy.
 
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Brand Name
CERELINK ICP MONITOR
Type of Device
ICP MONITOR-CERELINK
Manufacturer (Section D)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
11 cabot boulevard
mansfield MA
Manufacturer (Section G)
INTEGRA LIFESCIENCES MANSFIELD
11 cabot boulevard
mansfield MA
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key15105827
MDR Text Key296612987
Report Number3014334038-2022-00166
Device Sequence Number1
Product Code GWM
UDI-Device Identifier10381780533788
UDI-Public10381780533788
Combination Product (y/n)N
PMA/PMN Number
K183406
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number826820
Device Catalogue Number826820
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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