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

Catalog Number 0998-00-0800-53

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.

Event Description

The customer reported that when disconnecting the intra-aortic balloon (iab), a no alarm issue was discovered on the intra-aortic balloon pump (iabp).This event occurred during in-service training to the hospital nurse.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

09/19/2017 02:14 pm (gmt-4:00) added by (b)(6) (pid-(b)(4)): a getinge field service engineer (fse) evaluated the intra-aortic balloon pump (iabp) and reported that the iabp performed as designed.Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.

Event Description

The customer reported that when disconnecting the intra-aortic balloon (iab), a no alarm issue was discovered on the intra-aortic balloon pump (iabp).This event occurred during in-service training to the hospital nurse.There was no patient involvement and no adverse event was reported.

• 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: 6851853
• MDR Text Key: 86008444
• Report Number: 2249723-2017-00443
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/08/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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