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

Model Number N/A

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge service representative reported that the issue was fixed by exchanging the special seal.The iabp is now ready for clinical service, but has not yet been delivered to the customer.No further investigation is required.(b)(6).

Event Description

It was reported that during an ongoing repair that was being performed by a getinge service representative under mfg report number 2249723-2019-01548, the cardiosave intra-aortic balloon pump (iabp) had a helium gas leak that exceeded the criteria value of 20 psi in 5 minutes.There was no patient involvement, and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID INT TYP B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 9504320
• MDR Text Key: 191562094
• Report Number: 2249723-2019-02070
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• 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: 0998-00-0800-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2019
• 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