MAUDE Adverse Event Report: MED-DYNE, INC. MED-DYNE; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number G536L

Device Problems Loose or Intermittent Connection (1371); Device Damaged Prior to Use (2284)

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

Event Date 06/12/2017

Event Type  malfunction  

Event Description

The metal contact leads were loose from the gel pads when the package was opened.This apparently has been an ongoing issue requiring the use of tape to keep the metal contacts in place.

• Brand Name: MED-DYNE
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): MED-DYNE, INC.; 2775 s. floyd street; louisville KY 40209
• MDR Report Key: 6689059
• MDR Text Key: 79141205
• Report Number: 6689059
• Device Sequence Number: 1
• Product Code: DSA
• 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: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: G536L
• Device Catalogue Number: G536L
• Device Lot Number: 051731162
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1