MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC SURELIFE; BLOOD PRESSURE MONITOR

Catalog Number 860211

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Output Problem (3005)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 08/15/2022

Event Type  malfunction  

Event Description

End user reports that while using a surelife classic wrist blood pressure monitor from lot 51801, the monitor was giving false high readings.The classic wrist blood pressure monitor showed her systolic blood pressure at 207/117.The end user then went to urgent care around 1-2pm where the nursing staff insisted on calling the ambulance where she declined and said she would drive herself.The end user then went home to shower, then after she arrived to the emergency room around 5:00pm after driving herself.The end user was told to stay at the hospital but declined being admitted to a hospital room and left the hospital due to her blood pressure lowering.The hospital's arm blood pressure monitor was tested in comparison to the end user's classic wrist blood pressure monitor on her two arms at different times and the hospital's monitor read 178/100.The hospital staff told the end user that her surelife classic wrist blood pressure monitor needs calibration.

Manufacturer Narrative

Production records investigated for lot number 51801.The testing showed no indication of abnormalities or malfunction at time of production.

• Brand Name: SURELIFE
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 15245445
• MDR Text Key: 298106840
• Report Number: 3005798905-2022-03071
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 860211
• Device Lot Number: 51801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization