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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. HEMOPRO2 ADAPTER
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DATASCOPE CORP. HEMOPRO2 ADAPTER Back to Search Results
Model Number C-VH-4020
Device Problems Electrical /Electronic Property Problem (1198); Failure to Deliver Energy (1211)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2015
Event Type  malfunction  
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, hemopro extension cable and the hemopro 2 adapter did not have power from the generator to the hemopro 2 device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.(b)(4).
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
HEMOPRO2 ADAPTER
Manufacturer (Section D)
DATASCOPE CORP.
wayne NJ
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4881561
MDR Text Key21461034
Report Number2242352-2015-00524
Device Sequence Number0
Product Code KNS
Reporter Country CodeUS
PMA/PMN Number
K101274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,company representati
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2015
Device Operator Health Professional
Device Model NumberC-VH-4020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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