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

Catalog Number 860212

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Or Inadequate Test Results (2456)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 03/16/2018

Event Type  malfunction  

Event Description

Sporadic inaccurate readings.

Event Description

Sporadic inaccurate readings.

• Brand Name: SURELIFE
• Type of Device: BLOOD PRESSURE MONITOR
• Manufacturer (Section D): MHC MEDICAL PRODCUTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• MDR Report Key: 7653187
• MDR Text Key: 112916085
• Report Number: 3005798905-2018-00946
• 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: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 860212
• Device Lot Number: 43895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1