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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Loss of Power (1475); Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/25/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge service territory manager (stm) was dispatched to evaluate the iabp unit in addition to perform a scheduled preventative maintenance (pm).The stm performed the battery runtime test and noted that the battery passed to factory specifications and that the batteries had been replaced in (b)(6) 2019 during a previous pm service.The stm was unable to duplicate the customers reported issue and noted that the battery maintenance message is displayed every six months per pm protocol.As part of the pm, the stm installed a 2500 hr pm kit, and replaced the expired safety disk and worn cable clamps.The stm then completed pm service including all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) generated a "battery maintenance" message and it was noted that the battery "dies" quickly.It was also reported that the patient was taken off the floor for some fresh air for 5 minutes, and when removing the iabp unit from ac power, the battery indicated full charge.The iabp unit was brought with the patient, and set up so the patient could stand.Upon returning to the floor, the iabp lost all power.The patient was not dependent on the iabp.Within 3 minutes the patient was back on floor and in the room, with the unit being plugged back in.Total time off the floor was 15 minutes.No patient harm, serious injury or adverse event was reported.
 
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Brand Name
CS300
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key9369167
MDR Text Key190954767
Report Number2249723-2019-01877
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/22/2019
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 Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/04/2019
Initial Date FDA Received11/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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