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

Catalog Number 860213

Device Problem Output Problem (3005)

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

Event Date 08/03/2018

Event Type  malfunction  

Event Description

Bpm no longer is working correctly.The machine will come on, but won't display any numbers.I asked if any errors display on the screen, and she stated err.This has been going on for a couple of days now.

Event Description

Bpm no longer isn't working correctly.The machine will come on, but won't display any numbers.I asked if any errors display on the screen, and she stated err.This has been going on for a couple of days now.

• 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: 7840043
• MDR Text Key: 119018385
• Report Number: 3005798905-2018-00858
• 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: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 860213
• Device Lot Number: 1605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1