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

Catalog Number 860212

Event Date 07/19/2018

Event Type  malfunction  

Event Description

Not giving the correct reading.His normal bp range 145-147, his results from the machine will be 50/40.Just started using the device last night due to having an arm bpm; he uses on a regular basis.

Event Description

Not giving the correct reading.His normal bp range 145-147, his results from the machine will be 50/40.Just started using the device last night due to having an arm bpm he uses on a regular basis.

• 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: 7791520
• MDR Text Key: 117428420
• Report Number: 3005798905-2018-00806
• 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

• 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: 07/26/2018
• 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