MAUDE Adverse Event Report: MAQUET DATASCOPE CORP - CARDIAC ASSIST DIVISION DATASCOPE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 403072279

Device Problems Air Leak (1008); Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 04/17/2014

Event Type  malfunction  

Event Description

Received alert from iabp device that there was an air leak in the circuit.The staff confirmed that there were no loose connections.The device was rebooted and alarmed "electrical fault no.53".The pump was changed out and no alert regarding air in circuit was subsequently received.There was no harm to the patient.The manufacturer responded to the location and repaired an intermittent contact with the absolute pressure transducer connector.

• Brand Name: DATASCOPE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET DATASCOPE CORP - CARDIAC ASSIST DIVISION; 15 law drive; fairfield NJ 07004
• MDR Report Key: 3896651
• MDR Text Key: 4647610
• Report Number: 3896651
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/06/2014

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: Invalid Data
• Device Model Number: 403072279
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR