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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. ICP EXPRESS PRESSURE MONITOR; SPINAL FLUID PRESSURE MONITOR, ELECTRICAL
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CODMAN & SHURTLEFF, INC. ICP EXPRESS PRESSURE MONITOR; SPINAL FLUID PRESSURE MONITOR, ELECTRICAL Back to Search Results
Catalog Number 82-6635
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Information (3190)
Event Date 12/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device will be repaired in (b)(6).As such it is not possible to evaluate the product and determine the root cause of this complaint.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed.Device not available.
 
Event Description
As reported by the ous affilate, an icp displayed incorrect data, pressure values too high.Another was used to complete the procedure.There were no reports of delay or patient harm.
 
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Brand Name
ICP EXPRESS PRESSURE MONITOR
Type of Device
SPINAL FLUID PRESSURE MONITOR, ELECTRICAL
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key7138482
MDR Text Key95803938
Report Number1226348-2017-10997
Device Sequence Number1
Product Code GWM
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K945585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number82-6635
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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