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

Catalog Number 860213

Device Problems Image Display Error/Artifact (1304); No Device Output (1435)

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

Event Date 08/07/2018

Event Type  malfunction  

Event Description

Had the bpm for about 2 years and displays er 1 on the screen.

Event Description

Had the bpm for about 2 years and displays er 1 on the screen.

• 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: 7844440
• MDR Text Key: 119152326
• Report Number: 3005798905-2018-00876
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 860213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Date Manufacturer Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1