MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE RESCUE; 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) ecg port was loose.It is unknown under which circumstances this event occurred and whether there was patient involved or not; however, there was no adverse event reported.

Manufacturer Narrative

The customer called back and informed that no service visit was needed.The plastic piece on their ecg connector/cable itself was broken, and therefore would not correctly fit into the ecg connector on the machine.The customer stated that they were going to replace their cable and no visit was necessary.Additional information is being requested from the customer with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) ecg port was loose.It is unknown under which circumstances this event occurred.There was no patient involvement; thus no adverse event was reported.

• Brand Name: CARDIOSAVE RESCUE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 8078636
• MDR Text Key: 127565165
• Report Number: 2249723-2018-01974
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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: 0998-00-0800-83
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1