MAUDE Adverse Event Report: ST JUDE MEDICAL INC. PRESSUREWIRE AERIS; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQU

Model Number C12058

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2014

Event Type  malfunction  

Event Description

Unable to obtain wireless connection for heart cath guidewire mounted sensor.

• Brand Name: PRESSUREWIRE AERIS
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQU
• Manufacturer (Section D): ST JUDE MEDICAL INC.; one st jude medical dr; st paul MN 55117
• MDR Report Key: 4062552
• MDR Text Key: 4734245
• Report Number: 4062552
• Device Sequence Number: 1
• Product Code: DRG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/19/2014

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: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 4463290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2014
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 62 YR
• Patient Weight: 86