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

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit 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.A supplemental report will be sent upon receiving this information.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had the bp and ecg connectors loose.It is unknown under which circumstances this event occurred; however, there was no adverse event reported.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had the blood pressure (bp) and ecg connectors loose.It was later reported that the customer observed that the external slave bp jack had a little bit of play in it.It is unknown under which circumstances this event occurred; however, there was no adverse event reported.

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate this unit and advised that the unit was never taken out of service.The fse also stated that the unit was still in service when he first visited the site and the customer advised him that they would get back to him when they located the iabp.The fse never heard back from the customer, but went back on a later date and located the iabp in the icu storage closet.Upon evaluation of the unit, the fse was unable to reproduce the reported issue.The fse did not observe much play in the connectors, but went ahead and pulled the front cover off and tightened the ecg and bp jacks as much as possible.The fse then completed full functional testing and safety check to factory specifications.The unit passed all functional and safety tests per factory specifications and was returned to customer and cleared for clinical use.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7999923
• MDR Text Key: 124970208
• Report Number: 2249723-2018-01841
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• 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: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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