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

Model Number N/A

Device Problems Inaccurate Synchronization (1609); Compatibility Problem (2960)

Patient Problems Ventricular Tachycardia (2132); No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2020

Event Type  Injury  

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.A getinge field service engineer (fse) was dispatched to evaluate this unit at the request of the customer to ensure the unit was operating correctly.The fse performed a full check-out of the unit, no issue found.The equipment works to manufacturer specifications.The unit was returned to the customer and cleared for clinical use.

Event Description

It was reported by the customer that the ekg on the bedside is not the same as the iabp.It is unknown the circumstances in which the event occurred.It is also unknown if there was patient involvement.No adverse event has been reported.

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.

Event Description

It was reported that during patient use,the ekg on the bedside was not reading the same as the cardiosve intra-aortic balloon pump (iabp).It was later reported that the customer stated the patient was experiencing "v-tach" (ventricular tachycardia).

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10, h11.Corrected field: h1.

Event Description

It was reported that during patient use,the ekg on the bedside was not reading the same as the cardiosve intra-aortic balloon pump (iabp).It was later reported that the customer stated the patient was experiencing "v-tach" (ventricular tachycardia).

Event Description

It was reported that during patient use,the ekg on the bedside was not reading the same as the cardiosve intra-aortic balloon pump (iabp).It was later reported that the customer stated the patient was experiencing "v-tach" (ventricular tachycardia).

• 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: 9765049
• MDR Text Key: 185569326
• Report Number: 2249723-2020-00334
• Device Sequence Number: 1
• Product Code: DSP
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening