MAUDE Adverse Event Report: MEDTRONIC, INC. AUTOLOG; APPARATUS, AUTOTRANSFUSION

Model Number AUTOLOG

Device Problems Device Stops Intermittently (1599); Defective Device (2588); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 08/21/2014

Event Type  malfunction  

• Brand Name: AUTOLOG
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): MEDTRONIC, INC.; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 4262055
• Report Number: 4262055
• Device Sequence Number: 1
• Product Code: CAC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 08/22/2014

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: Unknown
• Device Model Number: AUTOLOG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1