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

Catalog Number 0998-00-0800-XX

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.Additional information is being requested 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 the cardiosave intra-aortic balloon pump (iabp) displayed error message power-up failed 14 (compressor not detected by iabp) during service test by a getinge authorized distributor.The service engineer checked system statistic in service menu and found that the total assisted hour were 1740 and when compressor output test was performed, the iabp failed to pass this test.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

The authorized (b)(4) distributor has advised that the compressor was replaced and all functional and safety tests were passed per factory specifications.Subsequently, the iabp was released to the customer and returned to clinical service.The correct event date is (b)(6) 2018.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) displayed error message power-up failed 14 (compressor not detected by iabp) during service test by a (b)(4) authorized distributor.The service engineer checked system statistic in service menu and found that the total assisted hour were 1740 and when compressor output test was performed, the iabp failed to pass this test.There was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE
• 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 Key: 7857708
• MDR Text Key: 119661459
• Report Number: 2249723-2018-01548
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0998-00-0800-XX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1