MAUDE Adverse Event Report: EDWARDS LIFESCIENCES BMEYE CC NEXFIN WRIST UNIT; PLETHYSMOGRAPH, IMPEDANCE

Model Number A1WU28

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

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

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.A follow-up submission will communicate the results of the device history record review, the returned product evaluation result(s), investigation, and conclusion.

Event Description

It was reported that during use, the nexfin single cuff wrist unit provided 'unreliable measurements.' further details regarding the values or meaning of 'unreliable measurements' were unable to be obtained.'the finger cuff sometimes inflated and occasionally did not.' additionally, halfway through a measurement, it occasionally stopped working.There was no allegation of patient compromise and no additional system-related devices were identified as suspect.

Manufacturer Narrative

The device was manufactured december 09, 2010 and review of the device history record supports that there were no non-conformances noted during the manufacturing of the referenced device.Additionally, no prior service has been documented for this device.The actual values, reported as ¿unreliable,¿ were requested; however, the information was unable to be ascertained.Examination of the returned device found no fault was found.No physical damage was found in the visual inspection.It is unknown whether procedural processes or a specific circumstance played a role in the customer's experience, as the fault could not be replicated and no other issues were detected.Edwards will continue to review and monitor all events.If action is required an appropriate investigation will be performed.

• Brand Name: CC NEXFIN WRIST UNIT
• Type of Device: PLETHYSMOGRAPH, IMPEDANCE
• Manufacturer (Section D): EDWARDS LIFESCIENCES BMEYE; hoogoorddeef 60; 1101 be amsterdam ; NL
• Manufacturer (Section G): EDWARDS LIFESCIENCES BMEYE; hoogoorddeef 60; 1101 be amsterdam ; NL
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5492430
• MDR Text Key: 40427673
• Report Number: 2015691-2016-00743
• Device Sequence Number: 1
• Product Code: DSB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K1122381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

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: No Information
• Device Model Number: A1WU28
• Device Lot Number: 4932761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1