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

Model Number N/A

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A supplemental report will be submitted if additional information is provided.

Event Description

It was reported that while in use on a patient, the ecg tracings were not present on the cardiosave intra-aortic balloon pump (iabp).The end user stated that the iabp was working in pressure trigger and the patient was stable.The heart rate (hr) was correctly displayed on the iabp screen despite no ecg present.The end user indicated that the ecg pads were replaced with no resolution, and that occasionally the ecg tracings were present.The customer did not want to swap out the iabp unit with another iabp unit in the facility seeing that it is an older model, and stated that the issue may be with the cable.The customer plans to purchase another cable as soon as possible.There was no harm or injury to patient and no adverse event was reported.

Event Description

It was reported that while in use on a patient, the ecg tracings were not present on the cardiosave intra-aortic balloon pump (iabp).The end user stated that the iabp was working in pressure trigger and the patient was stable.The heart rate (hr) was correctly displayed on the iabp screen despite no ecg present.The end user indicated that the ecg pads were replaced with no resolution, and that occasionally the ecg tracings were present.The customer did not want to swap out the iabp unit with another iabp unit in the facility seeing that it is an older model, and stated that the issue may be with the cable.The customer plans to purchase another cable as soon as possible.There was no harm or injury to patient and no adverse event was reported.

Manufacturer Narrative

At this time, the customer has not requested getinge to evaluate the iabp.Good faith effort (gfe) attempts to obtain the relevant repair and iabp status related to this complaint issue were made to the customer.However, despite our best efforts, the customer has not responded to any of our gfes.If additional information is provided in the future, we will submit a supplemental report.

• 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: 9273976
• MDR Text Key: 190374879
• Report Number: 2249723-2019-01758
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 60