MAUDE Adverse Event Report: NOVAPLUS RAW CUFF SOFT ADULT LONG DISPOSABLE BLOOD PRESSURE CUFF

Model Number	VSOFT-11L
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Disposable blood pressure cuff noted to be leaking air.Fda safety report id # (b)(4).

• Brand Name: NOVAPLUS RAW CUFF SOFT ADULT LONG DISPOSABLE BLOOD PRESSURE CUFF
• Common Device Name: BLOOD PRESSURE CUFF
• MDR Report Key: 12682218
• Report Number: MW5104882
• Device Sequence Number: 4550047
• Product Code: DXQ
• UDI-Device Identifier: 00732094227581
• UDI-Public: (01)00732094227581
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: VSOFT-11L
• Device Catalogue Number: VSOFT-11LUNO
• Device Lot Number: (01)21-221
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): No Information
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 96