MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Protective Measures Problem (3015); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.Additional information has been requested, and we will report accordingly when it becomes available.(b)(6).

Event Description

It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) alarmed ¿fault code# 60¿.The clinical staff replaced the iabp.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

A getinge service representative has advised that the customer has agreed for getinge to service and repair the iabp.It was also advised that a dealer¿s field service engineer (fse) authorized by getinge, evaluated the iabp unit and was unable to reproduce the reported issue.The dealer¿s fse performed a preventive maintenance (pm) on the iabp unit and replaced the 5,000hrs pm kit, performing safety disk leak test and k6, k6a, k7, k8 leak test and motor test and pneumatic performance test.The iabp was able to pass all the leak tests, and the iabp was then released to the customer and cleared for clinical service.

Event Description

It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) alarmed ¿fault code#60¿.The clinical staff replaced the iabp.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the cs100 iabp and was unable to duplicate the reported failure.In addition, the fse did not complete any repairs on the iabp as the customer refused to pay for the repairs.Consequently, the iabp has not been returned to the customer or to clinical service.

Event Description

It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) alarmed ¿fault code#60.¿ the clinical staff replaced the iabp.No patient harm, serious injury, or adverse event was reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10, h11.Corrected field: g4 of follow up emdr #2 (the mfg aware date was incorrectly reported; the correct date is (b)(6) 2019).

Event Description

It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) alarmed ¿fault code#: 60.¿ the clinical staff replaced the iabp.No patient harm, serious injury or adverse event was reported.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8550366
• MDR Text Key: 143859093
• Report Number: 2249723-2019-00666
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3013-45
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 06/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1