MAUDE Adverse Event Report: AMERICAN DIAGNOSTIC CORPORATION ADVANTAGE 6021N AUTOMATIC DIGITAL BP MONITOR; DIGITAL BLOOD PRESSURE MONITOR

Model Number	6021N
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
End user was using a model 6021n home automatic blood pressure monitor for the first time.The device inflated to high pressure (above 200 mmhg) in order to read the end user's blood pressure.This caused significant discomfort.The end user attempted to take her blood pressure three times, pressing the stop button the first time, trying to loosen the cuff before measurement the second time, and stopping the unit the third time.End user reported that her arm became very red and she had difficulty moving her forearm after measurement.She also reported difficulty squeezing her hand.Physical therapy relieved these symptoms.This device was received back and evaluated.The product contained readings relating to end user blood pressure and pulse at the time of incident.The readings were as follows: 161/115 with a pulse of 83, 188/127 with a pulse of 116, 186/122 with a pulse of 110.After reviewing the data on the device it was noted that this device would need to inflate to a range of 200 mmhg to 220 mmhg to take blood pressure readings in this range, which would typically be uncomfortable for most end users.The device was then tested using three test methods to verify that it was functioning properly: test - a safety feature test was performed to ensure that this device can not inflate above its maximum 300 mmhg which is the maximum allowed for an automated sphygmomanometer.This test was conducted by intentionally loosening the cuff such that proper inflation would not be possible during the device inflation process, which could result in over-inflation if the safety feature is not operating correctly.It was determined that this device successfully dumps pressure when a blood pressure is not detected prior to reaching this pressure and that the safety features are functioning as intended.Test - this device was tested against an nibp simulator which produces a simulated blood pressure of 120/80 to check the device for consistency of reading.The device met testing criteria and was within +/- 2 mmhg of simulator readings on four tests at pressures of 250/195, 200/144, 120/80, and 80/50.This test also demonstrated that the exhaust rate for this device is within expected tolerances.Test - finally, the device was tested on a live patient to ensure that the device was working as intended.The device was able to successfully inflate, take blood pressure, and deflate without issue.The device will also cease operation when the measurement button is pressed during operation, as intended.Based on our evaluation and testing of the device, we have determined that it is functioning as intended and that no device malfunction occurred.Due to the patient's blood pressure, the device would need to inflate to pressures around 200-220 mmhg to obtain a reading, likely resulting in the discomfort the patient experienced.These ranges are within normal operating parameters for this type of equipment.It is unknown if the patient has underlying conditions that would contraindicate the use of this type of device as it is inflating within normal functional ranges that should not result in patient injury.
Event or Problem Description
End user was using a model 6021n home automatic blood pressure monitor for the first time.The device inflated to high pressure (above 200 mmhg) in order to read the end user's blood pressure.This caused significant discomfort.The end user attempted to take her blood pressure three times, pressing the stop button the first time, trying to loosen the cuff before measurement the second time, and stopping the unit the third time.End user reported that her arm became very red and she had difficulty moving her forearm after measurement.She also reported difficulty squeezing her hand.Physical therapy relieved these symptoms.

• Brand Name: ADVANTAGE 6021N AUTOMATIC DIGITAL BP MONITOR
• Common Device Name: DIGITAL BLOOD PRESSURE MONITOR
• Manufacturer (Section D): AMERICAN DIAGNOSTIC CORPORATION; 55 commerce drive; hauppauge NY 11788
• MDR Report Key: 11663584
• Report Number: 2434008-2021-00001
• Device Sequence Number: 16912249
• Product Code: DXN
• UDI-Device Identifier: 00634782074791
• UDI-Public: 00634782074791
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K041411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 6021N
• Device Catalogue Number: 6021N
• Device Lot Number: 20100024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/14/2021
• 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: 45 YR