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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Failure to Calibrate (2440)
Patient Problem Death (1802)
Event Date 11/24/2018
Event Type  Death  
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.At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.
 
Event Description
It was reported that during use on a patient, the intra-aortic balloon pump (iabp) stopped pumping and generated a failure to calibrate alarm.The customer did not change the 40cc fiber optic cable balloon or the iabp.However, the user removed the fiber optic cable from the unit and allowed it to run off of the hemo pressure on semi-auto.The iabp therapy continued successfully and the patient was transferred to ccu.An hour later, the nurse noted that the iabp unit was alarming and notified the doctor.However, before the doctor could respond the patient coded and passed away.The date of the patient¿s death is unknown.The facility is not attributing the death to the device.The serial number or type of iabp involved in this event was not reported.The related iab report was submitted under mfg report# 2248146-2018-00741.
 
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Brand Name
UNKNOWN
Type of Device
SYSTEM, 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 Key8191536
MDR Text Key131221240
Report Number2249723-2018-02206
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Device Age YR
Initial Date Manufacturer Received 12/03/2018
Initial Date FDA Received12/21/2018
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
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age81 YR
Patient Weight67
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