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

Catalog Number 860213

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/25/2018

Event Type  malfunction  

Event Description

Bpm isn't pumping up like it used to, it displays a 0 and just flashes.She's tried it about 15 times, but it just wouldn't pump up like it should.

Event Description

Bpm isn't pumping up like it used to, it displays a 0 and just flashes.She's tried it about 15 times, but it just wouldn't pump up like it should.

• 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: 7712552
• MDR Text Key: 114801471
• Report Number: 3005798905-2018-00721
• 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: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 860213
• Device Lot Number: 1603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1