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: DATASCOPE CORP. TUBING PACK; CARDIOPULMONARY DEVICE
  • 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
 

DATASCOPE CORP. TUBING PACK; CARDIOPULMONARY DEVICE Back to Search Results
Model Number BO-TOP 23102
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/18/2014
Event Type  malfunction  
Event Description
It was reported that the cuvette was not secured onto the tubing.This was observed during priming.No injuries were reported.
 
Manufacturer Narrative
The device was not returned for evaluation; therefore a root cause could not be identified.Device history was reviewed and no non-conformance were found related to the reported event.If additional information is received or the device is returned, a follow-up report will be submitted.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TUBING PACK
Type of Device
CARDIOPULMONARY DEVICE
Manufacturer (Section D)
DATASCOPE CORP.
fairfield NJ
Manufacturer Contact
jason de sousa
15 law dr.
fairfield, NJ 07004-0011
9737097256
MDR Report Key4037151
MDR Text Key4725008
Report Number2248146-2014-00336
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBO-TOP 23102
Device Lot Number16448-10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/22/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-