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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. 4 TO 1 PLEGIOX SET; CARDIOPULMONARY DEVICE
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DATASCOPE CORP. 4 TO 1 PLEGIOX SET; CARDIOPULMONARY DEVICE Back to Search Results
Model Number BO-T 8060
Device Problems Device Packaging Compromised (2916); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2014
Event Type  malfunction  
Event Description
Peel-back corner of pack was found to be partially opened.Opening appears to be uniform.It was reported that the failure did not occur during use.For related complaints see mfr report number 2248146-2014-00016 and 2248146-2014-00017.
 
Manufacturer Narrative
The component was returned by the facility for evaluation on (b)(4) 2014.A follow-up report will be submitted when the investigation is complete.
 
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Brand Name
4 TO 1 PLEGIOX SET
Type of Device
CARDIOPULMONARY DEVICE
Manufacturer (Section D)
DATASCOPE CORP.
fairfield NJ
Manufacturer Contact
jason de sousa
15 law dr.
fairfield, NJ 07004
9737097256
MDR Report Key3941700
MDR Text Key15119932
Report Number2248146-2014-00015
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
Remedial Action Other
Type of Report Initial
Report Date 02/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2014
Device Model NumberBO-T 8060
Device Catalogue Number701055828
Device Lot Number14667-02
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/26/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2012
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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