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

Model Number 0998-00-0800-53

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

No repair information has been provided at this time.A supplemental report will be submitted upon receipt of additional information.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was converted to rescue mode with the battery icon visible on the screen and the "rescue" icon on the keypad.In addition, reloading the rescue portion into the hospital cart resulted in the pump converting back to a/c power with all the correct icons visible.It was later clarified that the pump converted to rescue mode with only the jostling required to change the helium tank.There was no harm or injury to the patient and no adverse event was reported.

Manufacturer Narrative

Updated fields - b4, d9, e1(site country, event site email), g3, g6, g7, h2, h3, h4, h6 (type of investigation, investigation findings, , investigation conclusions), h10, h11.Corrected fields - g2, e2, e3, h6(component codes).

Event Description

N/a.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13005519
• MDR Text Key: 284305960
• Report Number: 2249723-2021-02869
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Date Manufacturer Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 78 KG