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

Catalog Number 0998-00-0800-53

Device Problems Failure to Charge (1085); Device Maintenance Issue (1379); Retraction Problem (1536); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2017

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 the company standard operating procedure since the device manufacture date is greater than one year from the event date.The service territory manager (stm) replaced the li-ion battery pack and tether assembly.The stm then completed preventive maintenance and calibrated the iabp.The iabp passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.The full name of the initial reporter is (b)(6).It was shortened to (b)(6) as per the character limit.The initial reporter is a company service territory manager.His contact information is as follows: (b)(6).

Event Description

A company service territory manager (stm) reported that while performing routine preventive maintenance (pm) he found the cardiosave plugged in but the battery in slot 1 was not accepting a charge and not functional on portable operation.The stm noted that battery 2 was ok.The stm also noted that the doppler tether was not retracting.No patient involvement or adverse event 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: 6961302
• MDR Text Key: 90659000
• Report Number: 2249723-2017-00662
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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