Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 N/A
Device Problems Device Emits Odor (1425); Power Conditioning Problem (1474); Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
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 field service engineer (fse) evaluated the iabp unit and was able to confirm the reported issue.When the fse replaced the power supply, it was found that the cable to power supply was burned.The customer ordered the cable and the fse replaced it.Unfortunately, after replacement of the power supply and the cable, the fse noticed that the batteries still were not charging.The fse traced the fault to a pushed in pin on the bulkhead connector on the rescue.The fse had ordered a bulkhead connector and replaced it.The fse then 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.The defective parts will be returned to (b)(6) for failure investigation.Additional information has been requested, and we will report accordingly when it becomes available.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was malfunctioning, had a burning smell, and the biomedical engineer stated that the iabp unit was not running on ac power and confirmed that it was not disconnected between the console and the cart.No patient harm, serious injury or adverse event was reported.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was malfunctioning, had a burning smell, and the biomedical engineer stated that the iabp unit was not running on ac power and confirmed that it was not disconnected between the console and the cart.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
The suspected faulty power supply was returned to getinge¿s national repair center (nrc) for evaluation.A senior technician inspected the power supply and observed visible burn damage located by connector j3.The nrc could not test the power supply ue to the supply having visible burn damage.The power supply will be retained in the national repair center as per procedure.The suspected cable, ac status to mini board was returned to getinge¿s national repair center (nrc) for evaluation.A senior technician evaluated the cable, ac status to mini board and observed heavily burn damage.The nrc could not test the cable, ac status to mini board due to heavy burn damage.The cable, ac status to mini board will be retained in the national repair center as per procedure.The customer returned the suspected faulty cable, ac power cart to backplane to getinge¿s national repair center (nrc) for evaluation.A senior technician evaluated the cable, ac power cart to backplane with no visual damage observed.The field service engineer had observed that a pin second from the top of the connector had been pushed in.The fse had reseated the pin.The technician then installed the cable, ac power cart to backplane into cardiosave test fixture and it tested to factory specifications per cardiosave service manual and it passed testing due to the fse reseating the pin in the cable.The nrc is retaining the cable, ac power cart to backplane in the national repair center as per procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CARDIOSAVE HYBRID TYPE B PLUG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
MDR Report Key8471400
MDR Text Key140914886
Report Number2249723-2019-00516
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-