MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE BLOOD PRESSURE MODULE; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2021

Event Type  malfunction  

Event Description

Defective blood pressure module.Fda safety report id# (b)(4).

• Brand Name: BLOOD PRESSURE MODULE
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; 920 winter st. ; waltham MA 02451 1457
• MDR Report Key: 11966018
• MDR Text Key: 255445254
• Report Number: MW5101774
• Device Sequence Number: 1
• Product Code: DXN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR