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

Model Number R24AS

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2022

Event Type  malfunction  

Event Description

Leads found stuck to each other & infant's clothes.

• Brand Name: MED-DYNE
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): MED-DYNE, INC.; 2775 s. floyd st.; louisville KY 40209
• MDR Report Key: 14186274
• MDR Text Key: 289874636
• Report Number: 14186274
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: R24AS
• Device Catalogue Number: R24AS
• Device Lot Number: 022243945
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 120 DA
• Patient Sex: Male