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); Device Displays Incorrect Message (2591)

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

Event Date 08/06/2018

Event Type  malfunction  

Event Description

Initial inquiry: error p is showing on the screen during initial turn on but will inflate and show a bpm reading and inflate.She wants to be sure her readings are accurate.I called to speak with (b)(6) and she stated a p just shows up on the screen, not an err p.The p will just flash and then the machine will provide her with a reading that she's not comfortable with.She would like a replacement due to her having heart problems.

Event Description

Initial inquiry: error p is showing on the screen during initial turn on but will inflate and show a bpm reading and inflate.She wants to be sure her readings are accurate.I called to speak with phyllis and she stated a p just shows up on the screen, not an errp.The p will just flash and then the machine will provide her with a reading that she's not comfortable with.& nbsp; she would like a replacement due to her having heart problems.

• Brand Name: SURELIFE
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• MDR Report Key: 7844422
• MDR Text Key: 119152752
• Report Number: 3005798905-2018-00864
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K091415
• 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: 08/07/2018

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: 42793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 08/06/2018
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1