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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD CUSTOM BEQ-01930311 QUADROX-I PEDIATRIC; TUBING, PUMP, CARDIOPULMONARY BYPASS
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DATASCOPE CORP. - FAIRFIELD CUSTOM BEQ-01930311 QUADROX-I PEDIATRIC; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 70122028
Device Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 02/25/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
 
Event Description
It was reported during priming, the customer noticed a cracked connector.It was replaced.There was no patient involvement and therefore no reported injury.
 
Manufacturer Narrative
Additional information section h - evaluation method codes added: analysis of data provided by user/third party.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Reference complaint # (b)(4).
 
Event Description
It was reported during priming, the customer noticed a cracked connector.It was replaced.There was no patient involvement and therefore no reported injury.
 
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Brand Name
CUSTOM BEQ-01930311 QUADROX-I PEDIATRIC
Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key9837043
MDR Text Key185933631
Report Number2248146-2020-00150
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
PMA/PMN Number
K080592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number70122028
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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