MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC SURELIFE; BLOOD PRESSURE CUFF (ARM)

Model Number NOT PROVIDED

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2017

Event Type  malfunction  

Event Description

Customer receives "err p", "err 1", and "err 3" on display.

Manufacturer Narrative

Device was not returned to manufacturer, nor was there a lot number recorded to provide retained sample testing or attachment of production reccords.

Event Description

Customer receives "err p", "err 1", and "err 3" on display.

• Brand Name: SURELIFE
• Type of Device: BLOOD PRESSURE CUFF (ARM)
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 11930 kemper springs drive; cincinnati, oh OH 45240
• MDR Report Key: 7366552
• MDR Text Key: 103566123
• Report Number: 3005798905-2018-00001
• 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: 02/23/2018

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 Model Number: NOT PROVIDED
• Device Catalogue Number: 860214
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 02/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1