MAUDE Adverse Event Report: GYRUS ACMI DOL-TUB; TRANSDUCER TUBING

Catalog Number DOL-TUB

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2015

Event Type  malfunction  

Event Description

Transducer failure: could not make unit work.Another device obtained and procedure started.No patient harm.

• Brand Name: DOL-TUB
• Type of Device: TRANSDUCER TUBING
• Manufacturer (Section D): GYRUS ACMI; 136 turnpike rd; southborough MA 01772
• MDR Report Key: 5503524
• MDR Text Key: 40489186
• Report Number: 5503524
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/23/2017
• Device Catalogue Number: DOL-TUB
• Device Lot Number: S147051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR