MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Output below Specifications (3004)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

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 when subsequent information is provided.(b)(6).

Event Description

It was reported by the intensive care unit (icu) nurse (rn) that while in use in a patient, the cs300 intra-aortic balloon pump (iabp) produces frequent ¿low vacuum¿ alarms.The unit continues to alarm after a reboot.This issue has been occurring since yesterday.The iabp was switched out and labeled for biomed.There was no patient harm or injury and no adverse event reported.

Manufacturer Narrative

(the aware date was incorrectly reported in the first follow- up.The correct aware date was 31jul2019 instead of 14jun2019).

Event Description

It was reported by the intensive care unit (icu) nurse (rn) that while in use in a patient, the cs300 intra-aortic balloon pump (iabp) produces frequent ¿low vacuum¿ alarms.The unit continues to alarm after a reboot.This issue has been occurring since yesterday.The iabp was switched out and labeled for biomed.There was no patient harm or injury and no adverse event reported.

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.However the stm was able to verify the alarms in the iabp¿s diagnostic error log.Additionally, the stm noted that the o-rings were dirty on the back side of the safety disk.The stm cleaned the safety disk o-rings and then performed all functional and safety tests which passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.

Event Description

It was reported by the intensive care unit (icu) nurse (rn) that while in use in a patient, the cs300 intra-aortic balloon pump (iabp) produces frequent ¿low vacuum¿ alarms.The unit continues to alarm after a reboot.This issue has been occurring since yesterday.The iabp was switched out and labeled for biomed.There was no patient harm or injury and no adverse event reported.

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 8723428
• MDR Text Key: 149075168
• Report Number: 2249723-2019-00994
• 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,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• 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: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 97