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 Problems Electrical /Electronic Property Problem (1198); Appropriate Term/Code Not Available (3191)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a power cord failure.It is unknown under which circumstances this occurred; however there was no known harm or injury to patient and no adverse event was reported.

Manufacturer Narrative

At this time, the customer has not requested getinge to evaluate the iabp.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Manufacturer Narrative

Corrected fields: b5, d10, h3, h6 (medical device ¿ problem code, type of investigation, component codes, health effect ¿ impact codes), h10.Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse observed that the power cord was not retracting and troubleshooting revealed that the power cord was wrapped around a guide.The fse unwrapped the cord and then observed that the power cord assembly retracted.Subsequently, the fse performed scheduled preventative maintenance (pm).The unit passed all calibration, functional, and safety tests per factory specifications.The unit was returned to the customer and has been cleared for clinical use.A supplemental report will be submitted upon completion of our investigation.An additional customer contact was provided and is as follows: (b)(6).

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a bad power cord.There was no patient harm and no adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, e1(event site email), e2, e3, g3, g4, g7, g8, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person).

• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13101845
• MDR Text Key: 286253193
• Report Number: 2249723-2021-02974
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2022

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 Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 01/12/2022; 08/07/2022
• Supplement Dates FDA Received: 02/04/2022; 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1