MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC VPAD PATIENT TRACKER

Model Number	INS-0050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
While anesthesia was putting the patient under she had brachycardia and started crashing, compressions were started and they called for a crash cart.Veran rep stepped out of the room.Only vpads had been placed for ct, the pads were not plugged into the cart yet, tower still off to the side in the room.The crash cart was not utilized but the patient was intubated and admitted to the icu.Staff informed veran rep that the patient is awake and talking in the icu.Pacemaker was placed the following monday, (b)(6) 2020.

• Brand Name: VPAD PATIENT TRACKER
• Common Device Name: VPAD PATIENT TRACKER
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC; 1938 innerbelt business center; saint louis MO 63114
• MDR Report Key: 10660143
• Report Number: 3007222345-2020-00010
• Device Sequence Number: 19619561
• Product Code: JAK
• UDI-Device Identifier: 00815686020408
• UDI-Public: 00815686020408
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K122106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: INS-0050
• Device Catalogue Number: INS-0050
• Device Lot Number: 03806200214
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR