• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE MAHWAH UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Failure to Advance (2524)
Patient Problems Death (1802); Myocardial Infarction (1969)
Event Date 03/08/2018
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. The customer reported that the patient's death was not due to any malfunction of the pump. The complaint originated due to an issue with the iab not advancing through the sheath. There was no alleged malfunction of the iabp, therefore the customer did not provide any information related to the iabp involved.
 
Event Description
It was reported that a patient presented with ami (acute myocardial infarction). The first intra-aortic balloon (iab) would not advance, however the second iab was able to advance. The patient was transferred to higher level of care via ambulance, supported on intra-aortic balloon pump (iabp). It was later reported that the patient died. There was no reported malfunction of the iabp. This complaint is related to iab complaint# (b)(6) and mfg report# 2248146-2018-00.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN
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 Key7480884
MDR Text Key107168355
Report Number2249723-2018-00742
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,health
Reporter Occupation
Type of Report Initial
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received04/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/02/2018 Patient Sequence Number: 1
-
-