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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Failure to Sense (1559); Optical Problem (3001)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 04/10/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge service territory manager (stm) was dispatched to evaluate the iabp and observed multiple occurrences of fault 53 "fos continuous bit failed" in the unit's diagnostic logs.The stm replaced fos assembly to resolve the issue.The unit passed all functional and safety tests to factory specifications.The iabp was returned to the customer and cleared for clinical use.
 
Event Description
It was reported by the customer that the cardiosave intra-aortic balloon pump (iabp) displayed a fiber optic module error.It is unknown if there was patient involvement; however there was no adverse event reported.
 
Manufacturer Narrative
Updated fields: b4, d5, g4, g7, h2, h10.Corrected fields: h6 (device codes).
 
Event Description
It was reported by the customer that the cardiosave intra-aortic balloon pump (iabp) displayed a fiber optic module error.It is unknown if there was patient involvement; however there was no adverse event reported.
 
Event Description
It was reported by the customer that the cardiosave intra-aortic balloon pump (iabp) displayed a fiber optic module error.It is unknown if there was patient involvement; however there was no adverse event reported.
 
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Brand Name
CARDIOSAVE HYBRID TYPE B PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key10017629
MDR Text Key193130461
Report Number2249723-2020-00698
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 06/04/2020
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 Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/10/2020
Initial Date FDA Received05/01/2020
Supplement Dates Manufacturer Received06/02/2020
06/02/2020
Supplement Dates FDA Received06/04/2020
06/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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