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

Catalog Number 0998-00-0800-53

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Event Description

The customer reported that they had 3 ekg cables not work.The alleged malfunction occurred while in use on a patient.No adverse event was reported.No patient injury or harm reported.

Event Description

The customer reported that they had 3 ekg cables not work.The alleged malfunction occurred while in use on a patient.No adverse event was reported.No patient injury or harm reported.

Manufacturer Narrative

08/29/2017 02:32 pm (gmt-4:00) added by (b)(4) (pid(b)(4)): please note that the date the email was received should read 21-july-2017 instead of 210july-2101.08/29/2017 12:21 pm (gmt-4:00) added by (b)(4) (pid-(b)(4)): as per email from the cardiac assist territory manager (catm) received 210july-21017, the customer is not alleging any malfunction of the intra-aortic balloon pump (iabp).The iabp worked fine with other cables.The customer is logging this complaint only for the ekg cable and not for the iabp itself.08/28/2017 04:08 pm (gmt-4:00) added by (b)(4) (pid-(b)(4)): this complaint is being closed due to insufficient information from the cardiac assist territory manager (catm) after six (6) attempts were made to obtain the relevant information.If further information is received in the future, a follow up will be submitted.

Event Description

The customer reported that they had 3 ekg cables not work.The alleged malfunction occurred while in use on a patient.No adverse event was reported.No patient injury or harm 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: 6712308
• MDR Text Key: 80047918
• Report Number: 2249723-2017-00093
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: No
• 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