MAUDE Adverse Event Report: SYNCHRONIS MEDICAL REGARD; PAD DEFIB RADIOTRNSPT ADLT PED W PHYSIO

Model Number	335561REG
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
The adhesive on this pad is very loose.When the team is doing chest compressions on the coding patient, the pads pop off.The team had to stop compressions and re stick the pad onto the patient to analyze the rhythm.We have had 3 instances so far, where the new defibrilator pads come off the patient's chest while we are doing chest compressions.(b)(4).

• Brand Name: REGARD
• Common Device Name: PAD DEFIB RADIOTRNSPT ADLT PED W PHYSIO
• Manufacturer (Section D): SYNCHRONIS MEDICAL; 4401 varsity drive suite d; ann arbor, mi
• MDR Report Key: 9996209
• Report Number: 3004513970-2020-00001
• Device Sequence Number: 11399448
• Product Code: MKJ
• UDI-Device Identifier: 20326053106013
• UDI-Public: 20326053106013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 335561REG
• Device Catalogue Number: 335561REG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1