MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problems Break (1069); Grounding Malfunction (1271); Physical Resistance/Sticking (4012)

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

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) the cardiosave intra-aortic balloon pump (iabp) fo-connector was defective.The blue housing from the connector was broken.The protective earth resistance infinitely and i the top screen was difficult to open.There was no patient involvement reported.

Manufacturer Narrative

The getinge service territory manager (stm) that discovered the issue replaced the connector, line cord assembly and both hinges (left and right).Performed pm, functional checks and safety check.The failure analysis and testing department inspected a cbl assy, fo sensor extension, p/n 0012-00-1562, and observed the extension was crack/broken.(see pics).No further test can be done due to the broken extension.Retaining the cbl assy, fo sensor extension in the failure analysis and testing department per procedure.The root cause selection for this investigation will be ¿impossible to define¿ due to the department not having the capabilities to troubleshoot this part internally further in an attempt to determine the root cause.The failure analysis and testing department inspected two hinges display, left p/n d105-00-0138-01 and right p/n d105-00-0138-01 and observed that the two parts are quite rugged and stuck, if too much torque is applied it may damage or break either part.The hinges could not be tested because they are stuck.Retaining the hinges in the failure analysis and testing department per procedure.The root cause selection for this investigation will be ¿¿impossible to define¿¿ due to the department not having the capabilities to troubleshoot this part internally further in an attempt to determine the root cause.The failure analysis and testing department received a reel ac power cord, cee 7/7 type e/f, p/n d012-00-1688-08, with a reported of ¿earth resistance infinity¿.Performed visual inspection per the cardiosave service manual and found no visual damage and the part looks to be in good condition.Tested the prongs and connectors with a fluke multimeter 12218.Found that all the resistance points were normal.The failure analysis and testing department was unable to replicate the failure experienced by the customer.Retaining the reel ac power cord, cee 7/7 type e/f in the failure analysis and testing department per procedure.The root cause selection for this investigation will be ¿not confirmed¿ due to the failure analysis and testing department was unable to replicate the failure.

• Brand Name: CARDIOSAVE HYBRID W/ E/F 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: 18387246
• MDR Text Key: 331487193
• Report Number: 2249723-2023-05443
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1