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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-XX
Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2017
Event Type  malfunction  
Manufacturer Narrative
09/12/2017 12:47 pm (gmt-4:00) added by (b)(4) (pid-(b)(4)): the updated and corrected fields previously reported should read as: corrected field: 08/02/2017 (the date entered in the initial mdr was incorrect, and should have been (b)(4)2017). 09/08/2017 03:32 pm (gmt-4:00) added by (b)(4)(pid-(b)(4)): a getinge company representative stated that the hospital ordered the parts & their own in-house medical physics repaired & replaced the parts. Details of the repair and parts replaced were not provided.
 
Event Description
The customer reported that the intra-aortic balloon pump (iabp) alarmed and stopped inflating when repositioning the patient. When investigating the alarm and checking the tubing, there was clearly blood visible in the tubing connecting intra-aortic balloon pump (iab) catheter to iabp machine. The medical staff was called, tubing was clamped and decision was made to remove iabp and sheath as the customer was unable to remove catheter alone. The catheter, tubing and machine were then sent to medical physics for investigation. This event occurred while in use on a patient. No adverse event was reported. It was later reported that the alarm that occurred during the event was "standby one minute".
 
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint. Additional information has been requested from the maquet/getinge business unit. If the information is provided, it will be reported accordingly.
 
Event Description
The customer reported that the intra-aortic balloon pump (iabp) alarmed and stopped inflating when repositioning the patient. When investigating the alarm and checking the tubing, there was clearly blood visible in the tubing connecting intra-aortic balloon pump (iab) catheter to iabp machine. The medical staff was called, tubing was clamped and decision was made to remove iabp and sheath as the customer was unable to remove catheter alone. The catheter, tubing and machine were then sent to medical physics for investigation. This event occurred while in use on a patient. No adverse event was reported.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key6812001
MDR Text Key104180805
Report Number2249723-2017-00320
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-0800-XX
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received08/23/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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