MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. EASY TOUCH; BLOOD PRESSURE MONITOR

Catalog Number 860211

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2018

Event Type  malfunction  

Event Description

Readings are incorrect.449/444 would read a funny codes or give different high numbers 060/ 020.

• Brand Name: EASY TOUCH
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnnati, OH 45240
• MDR Report Key: 7521078
• MDR Text Key: 108488566
• Report Number: 3005798905-2018-00515
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2018

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 860211
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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