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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAUMEDIC AG NEUROVENT-P; NEUROLOGICAL CATHETER

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RAUMEDIC AG NEUROVENT-P; NEUROLOGICAL CATHETER Back to Search Results
Model Number 092946-001
Device Problem No Device Output (1435)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/18/2018
Event Type  malfunction  
Manufacturer Narrative
Manufacturer statement: for evaluation of the malfunction dhr documents were reviewed.They demonstrate that the catheter neurovent-p (sn (b)(4)) met specification during manufacturing.Final inspection of the finished catheter was passed.This demonstrates that the catheter has been manufactured and sold in conformance to relevant specifications.Furthermore returned catheter was investigated.This investigation demonstrates that one wire is torn apart from the soldering pads on the pcb.Based on knowledge that the final inspection of the finished catheter was passed, that the catheter was delivered with proper functionality and in consideration of the results of performed investigation of returned catheter, the tear-off of the wire is caused by user error by stretching of the catheter during application contrary to ifu.[(b)(4)].
 
Event Description
After implantation of the catheter icp could be monitored for 1 hour.Afterwards icp measurement was no more possible.So the catheter was replaced by a new catheter.No additional anesthesia and no additional medicinal treatment was necessary.Health condition of the patient was not influenced by this.
 
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Brand Name
NEUROVENT-P
Type of Device
NEUROLOGICAL CATHETER
Manufacturer (Section D)
RAUMEDIC AG
am mühlgraben 10
zwönitz, 08297
GM  08297
Manufacturer (Section G)
RAUMEDIC AG
am mühlgraben 10
zwönitz, 08297
GM   08297
Manufacturer Contact
reiner thiem
hermann-staudinger-strasse 2
helmbrechts, 95233
GM   95233
MDR Report Key8063755
MDR Text Key128052387
Report Number3006942548-2018-00005
Device Sequence Number1
Product Code GWM
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/13/2018
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
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Model Number092946-001
Device Catalogue Number092946-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2018
Initial Date Manufacturer Received 10/18/2018
Initial Date FDA Received11/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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