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

Catalog Number 860212

Device Problems No Device Output (1435); Low Readings (2460)

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

Event Date 07/19/2018

Event Type  malfunction  

Event Description

Receives errors, no longer talks nor works.It worked for a couple weeks, then all of a sudden just stopped.

Event Description

Receives errors, no longer talks nor works.It worked for a couple weeks, then all of a sudden just stopped.

• 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: 7791529
• MDR Text Key: 117428142
• Report Number: 3005798905-2018-00807
• 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: 08/01/2018

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: 860212
• Device Lot Number: 42795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1