Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM COOL LINE CATHETER; CENTRAL VENOUS CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZOLL CIRCULATION ZOLL IVTM COOL LINE CATHETER; CENTRAL VENOUS CATHETER Back to Search Results
Catalog Number 8700-0786-40
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/27/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The zoll catheter in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.The customer stated that the event was cause by patient anatomy.
 
Event or Problem Description
It was reported that a female patient treated for therapeutic hypothermia, the cool line catheter came out when the patient change her body position.The catheter was placed in the internal jugular vein for approximately 30 minutes dwell time.According to the customer," artic sun" was used to continue the treatment.Customer also reported that the catheter was too long due to the patient body size.The catheter was anchored to the patient with a suture tab clip.No patient harm or consequence was reported on this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZOLL IVTM COOL LINE CATHETER
Common Device Name
CENTRAL VENOUS CATHETER
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
MDR Report Key6808687
Report Number3010617000-2017-00691
Device Sequence Number132074
Product Code NCX
UDI-Device Identifier00849111075183
UDI-Public00849111075183
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K101987
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 08/21/2017
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 Catalogue Number8700-0786-40
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/28/2017
Initial Report FDA Received Date08/21/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-