MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Component Incompatible (1108); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) indicated that the customer needed the transducer cable only.A supplemental report will be submitted when additional information is provided.Not returned to manufacturer.

Event Description

It was reported that the transducer plug to balloon pump connections on the cardiosave intra-aortic balloon pump (iabp) do not match.There was no patient involvement and no adverse event was reported.

Event Description

It was reported that the connections of the transducer's plug to the cardiosave intra-aortic balloon pump (iabp) did not match.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

Additional information was requested from the customer with regard to the repair and status of the iabp.The customer reported that they were not sure how they were left with cables that did not fit the iabp; however, the cables were replaced and the iabp was cleared for clinical use.

Event Description

It was reported that the connections of the transducer's plug to the cardiosave intra-aortic balloon pump (iabp) did not match.There was no patient involvement and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 10601227
• MDR Text Key: 209016304
• Report Number: 2249723-2020-01583
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2021

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
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 10/19/2020; 01/12/2021
• Supplement Dates FDA Received: 11/12/2020; 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1