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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Retraction Problem (1536); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/18/2019
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 field service engineer (fse) was dispatched to the customer's site and after evaluating the iabp unit, was able to verify the customer's reported issue.No parts were replaced and the details of the evaluation have been requested.The fse has advised that iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted if additional information is provided.
 
Event Description
It was reported that during use on a patient, the line cord for the cardiosave intra-aortic balloon pump (iabp) was blocked inside the cart and the length was too short to connect to ac power.The customer swapped out the iabp unit with another iabp unit to continue therapy without issue.There was no patient harm and no adverse event reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) reported that the customer had not requested getinge to service the iabp.However, the customer provided repair information to the fse and reported that the customer's biomedical engineer was able to reproduce the reported issue before the repairs.The biomed opened the carter and put back the cord in the reel.The iabp unit was then returned and cleared for clinical use.Not returned to manufacturer.
 
Event Description
It was reported that during use on a patient, the line cord for the cardiosave intra-aortic balloon pump (iabp) was blocked inside the cart and the length was too short to connect to ac power.The customer swapped out the iabp unit with another iabp unit to continue therapy without issue.There was no patient harm and no adverse event reported.
 
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Brand Name
CARDIOSAVE HYBRID TYPE E/F PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key9179522
MDR Text Key190338456
Report Number2249723-2019-01641
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,foreig
Type of Report Initial,Followup
Report Date 11/04/2019
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 Model NumberN/A
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/18/2019
Initial Date FDA Received10/11/2019
Supplement Dates Manufacturer Received10/08/2019
Supplement Dates FDA Received11/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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