MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD VERIS MR VITAL SIGNS MONITOR; MONITOR, PHYSIOLOGICAL PATIENT,

Model Number 59352486

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

A system service check of the veris mr vital signs monitor, serial number (b)(4), has been scheduled but not yet completed.Further investigation is ongoing.Once the evaluation is completed, a follow-up report will be submitted.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.

Event Description

The site reported the following: an 80 year old patient was undergoing an mri scan of the brain and lumbar spine for possible stroke encephalopathy on a 1.5 tesla magnet and was connected to a veris mr vital signs monitor.It was reported that the blood pressure and pulse oximetry failed to display on the monitor.While a staff nurse was monitoring the procedure, the patient suffered a cardiac arrest.The site code team responded and the patient was successfully resuscitated and placed on a ventilator.The current status of the patient is unknown.

Manufacturer Narrative

A bayer service representative visited the site on december 30, 2020.Service tested and inspected all cables of the veris mr vital signs monitor (serial number (b)(6)) and verified normal operation of the blood pressure and pulse oximetry functions.A review of the completed customer questionnaire received by bayer found that, despite the pulse oximeter not working on any of the patient's fingers, the pulse oximeter worked immediately on a caregiver's hand.There are several possible reasons as to why the pulse oximeter did not pick up a signal from the patient, one of which could have been poor circulation in the fingers where the probe was placed; however, this cannot be confirmed.Bayer product analysis reviewed the information that was provided and determined that there is no evidence of a product malfunction.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.

• Brand Name: MEDRAD VERIS MR VITAL SIGNS MONITOR
• Type of Device: MONITOR, PHYSIOLOGICAL PATIENT,
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• MDR Report Key: 11032184
• MDR Text Key: 222278593
• Report Number: 2520313-2020-00042
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K042569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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
• Device Operator: Health Professional
• Device Model Number: 59352486
• Device Catalogue Number: VERIS
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 80 YR