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

Model Number N/A

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Failure to Shut Off (2939)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/30/2018

Event Type  malfunction  

Event Description

Err displayed on the screen.Thought it may be the batteries so they purchased new ones.When he tried to take his pressure the machine wouldn't shut off after taking his blood pressure.

Event Description

Err displayed on the screen.Thought it may be the batteries so they purchased new ones.When he tried to take his pressure the machine wouldn't shut off after taking his blood pressure.

• Brand Name: EASY TOUCH
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 11930 kemper springs drive; cincinnati OH 45240
• MDR Report Key: 7471398
• MDR Text Key: 107355957
• Report Number: 3005798905-2018-00483
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K091434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 860213
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1