MAUDE Adverse Event Report: COOK INCORPORATED COOK-SWARTZ; TRANSDUCER, ULTRASONIC

Model Number G21363

Device Problems Failure To Adhere Or Bond (1031); Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 10/26/2017

Event Type  malfunction  

Event Description

The probe was not glued well to the cuff and didn't work.

• Brand Name: COOK-SWARTZ
• Type of Device: TRANSDUCER, ULTRASONIC
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7052698
• MDR Text Key: 92778364
• Report Number: 7052698
• Device Sequence Number: 1
• Product Code: ITX
• 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: 10/31/2017,11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2019
• Device Model Number: G21363
• Device Catalogue Number: DP-SDP001
• Device Lot Number: N140809
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2017
• 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