MAUDE Adverse Event Report: HEART SYNC INC ADULT/CHILD, RADIOLUCENT, LEADS OUT, DEFIB ELECTRODES W/ PHILLIPS CONNECTOR; ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION

Model Number T100LOAC-PHILIPS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2018

Event Type  malfunction  

Event Description

During a mock code, it was found that if the paper backing from the defibrillator pads were removed incorrectly (i.E.From the opposite end, instead of the "peel here only") the conduction gel can be removed with the paper.Without the conduction gel, the patch may be unable to assess cardiac rhythm or deliver a shock.

• Brand Name: ADULT/CHILD, RADIOLUCENT, LEADS OUT, DEFIB ELECTRODES W/ PHILLIPS CONNECTOR
• Type of Device: ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
• Manufacturer (Section D): HEART SYNC INC; 4401 varsity drive; suite d; ann arbor MI 48108
• MDR Report Key: 7540199
• MDR Text Key: 109118374
• Report Number: 7540199
• Device Sequence Number: 1
• Product Code: MLN
• 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: 05/18/2018,05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 02/09/2021
• Device Model Number: T100LOAC-PHILIPS
• Device Catalogue Number: T100LOAC-PHILIPS
• Device Lot Number: Y020918-01
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2018
• 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