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

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG 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 CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: (10/213) a getinge field service engineer (fse) evaluated the iabp and connected patient simulator and provided a variety of waves, the nsr, sine, square, and triangle waves with no noise at all and could not duplicate the issue. There was an observation mentioned that the connector was wet, which i was able to confirm as there was dried salt from saline spill near the connector. The connector itself was a bit chewed but was not affecting performance. But, there was dried salt that could have also been seen in the crevice under the vent (above the batteries) and a little in the front section of the battery bay. It is not believed the batteries were damaged due to this spill. The fse performed all functional and safety checks to meet factory specifications. Unit passed all functional and safety test per factory specifications. The iabp was then released to the customer and cleared for clinical service. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use on a patient the cardiosave intra-aortic balloon pump (iabp) had a noisy ecg. No patient harm, serious injury or adverse event was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12332583
MDR Text Key266939026
Report Number2249723-2021-01842
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/17/2021 Patient Sequence Number: 1
Treatment
7.5FR 40CC
-
-