MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0998-00-0800-53

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

On 08/16/2017 09:25 am (gmt-4:00) added by (b)(4).The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge service territory manager (stm) was dispatched to evaluate the iabp and verified with the customer that the patient did not have an ecg or blood pressure waveform.The patient was revived and the iabp functioned properly.The iabp was switched due to ethernet connection not communicating with his system.The stm confirmed the problem with the ethernet connection to his system was due to the customer's defective lan cable.The customer supplied a new cable.The stm verified the iabp communicates with the his system.The stm tested the iabp and found it functions according to factory specifications.But the stm did verify multiple fault code 53 entries logged before and during testing.The stm reloaded the software per service manual and retested for 1 hour and verified no new fault code 53 was logged.The stm verified the iabp was fully calibrated and passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.

Event Description

The customer reported that the intra-aortic balloon pump (iabp) alarmed, lost wave forms, and shut down while on a patient.The patient coded and was revived.The iabp was replaced with another.The customer is not blaming the loss of waveforms on the iabp.The patient was very ill.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 6798611
• MDR Text Key: 82842484
• Report Number: 2249723-2017-00299
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR