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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP., BEQ-TOP 48000; CARDIOPULMONARY
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DATASCOPE CORP., BEQ-TOP 48000; CARDIOPULMONARY Back to Search Results
Catalog Number 701066398
Device Problems Break (1069); Kinked (1339)
Patient Problem No Patient Involvement (2645)
Event Date 08/12/2014
Event Type  malfunction  
Event Description
The customer sent emails with pictures documenting significant damage to the disposables in the tubing pack.The arterial sampling pigtail was kinked and the 1/4 inch outlet from the reservoir was broken off.
 
Manufacturer Narrative
The device is currently under investigation.Upon completion of the investigation, a supplemental will be sent with the results.(b)(4).
 
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Brand Name
BEQ-TOP 48000
Type of Device
CARDIOPULMONARY
Manufacturer (Section D)
DATASCOPE CORP.,
fairfield NJ
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097256
MDR Report Key4110135
MDR Text Key15181784
Report Number2248146-2014-00382
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,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/13/2014
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 Date07/03/2016
Device Catalogue Number701066398
Device Lot Number17317-04
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/20/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/13/2014
Initial Date FDA Received09/11/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2014
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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