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

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint.A getinge company representative has reported that the cable in question is well out of warranty and will not be replaced; as a result, the customer is not willing to send back the cable.The customer has multiple pumps and cables and was unable to provide the serial number of the related iabp.At this time, the customer has not requested getinge service.If additional information is made available, a supplemental report will be submitted.

Event Description

It was reported that the blood pressure transducer adapter cable that was received with the customer¿s cardiosave intra-aortic balloon pump (iabp) when it was new has never worked.This event was discovered during a routine check by the customer.The customer has further requested that the cable be exchanged at no charge.There was no patient involvement; thus 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: 7879678
• MDR Text Key: 120526718
• Report Number: 2249723-2018-01603
• 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: Other
• Type of Report: Initial
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/15/2018
• 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