MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC FLOTRAC, VAMP; TRANSDUCER, BLOOD-PRESSURE

Model Number MHD6AZ

Device Problems Material Fragmentation (1261); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 03/05/2019

Event Type  malfunction  

Event Description

The end of device where the stopcock is located was "wobbly".Nurse unscrewed it from the white rectangular portion and bits of plastic fell out.

• Brand Name: FLOTRAC, VAMP
• Type of Device: TRANSDUCER, BLOOD-PRESSURE
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 8431573
• MDR Text Key: 139168142
• Report Number: 8431573
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00690103194722
• UDI-Public: (01)00690103194722
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MHD6AZ
• Device Catalogue Number: MHD6AZ
• Device Lot Number: 61719567
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1