MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300, ENGLISH,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3013-53

Device Problem Connection Problem (2900)

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

Event Date 07/04/2021

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted if additional information is provided.The full name of the event site was shortened due to field character limit; the full name is (b)(6).Customer did not request service.

Event Description

It was reported by the customer during use, that there was no ecg waveform in the cs300 intra-aortic balloon pump (iabp) while in auto/pressure trigger.The customer informed us that the ecg pads were replaced and all ecg trunk cable connections and lead were checked.Getinge help support advised that they should consider trying another cable but customer reported that no pump or cable were available, they were locked in the cath lab at that time.Subsequently, a facetime call showed a sporadic ecg and scrolling through leads 1,2,and 3.The customer did not have an external access.Attempted scrolling through leads in semi auto and there was a consistent waveform in the avr, avl leads.Help support advised now to place in ecg trigger, but will need to time the pump.Since the customer was not familiar with this, an attempt was made to assist with timing but there was an understanding and a language barrier.Finally, another attempt at auto was made and consistent ecg was present, now in lead 1.The help support advised again that they should consider another cable and/or pump to rule out a problem with either.They will report this pump to their biomed department once available.No patient harm, serious injury or adverse event was reported.

• Brand Name: CS300, ENGLISH,NON-UTS,DOM
• 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: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12246395
• MDR Text Key: 264107921
• Report Number: 2249723-2021-01630
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: 10607567107394
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2004
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 69