MAUDE Adverse Event Report: DATASCOPE CORP. DATASCOPE CARDIOSAVE RESCUE CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number CS300

Device Problems Device Alarm System (1012); Loss of Power (1475); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2019

Event Type  malfunction  

Event Description

Patient was being transferred from icu to the cath lab for impella placement with intra-aortic balloon pump (iabp) in place and on battery.Upon arrival to the cath lab, the iabp console shut off.The console was immediately plugged into an outlet, the device came on but was not functioning properly.Staff unable to palpate pulses and cpr was initiated.Manufacturer response for circulatory assist unit, cardiac, intra-aortic balloon pump, datascope cardiosave rescue (per site reporter).A getinge service rep inspected and serviced the device."began diagnostics and battery run test.Unit died 17 minutes into battery test.Ordered and replaced batteries.Complete pm with full calibration, functional testing and safety check to factory specifications.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use." fault codes/(b)(4).Battery performance.Batteries failed-wont hold charge.Last preventative maintenance (pm) by getinge service rep was a few months ago."completed pm with full calibration, functional testing and safety check to factory specifications.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.".

• Brand Name: DATASCOPE CARDIOSAVE RESCUE CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law dr.; fairfield NJ 07004
• MDR Report Key: 8825848
• MDR Text Key: 152176504
• Report Number: 8825848
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CS300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2019
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 79