MAUDE Adverse Event Report: WELCH ALLYN PROPAQ CS 246

Model Number 246CS/GERMAN/SPN/WAFN/IEC/PLUGC

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

Our evaluation of this incident is not yet complete.A follow-up report will be submitted when the evaluation is complete.

Event Description

Welch allyn received a report from a welch allyn customer stating that their device was intermittently shutting down during use without alarms or alerts.There was no death or injury associated with this complaint.Note: the customer did not provide any patient information.This complaint was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

Welch allyn service could not duplicate the customer allegation of an unexpected shutdown.The unit passed all testing and the original battery that was sent back with the unit had sufficient capacity to operate with alarms and alerts functionally normally.The device functioned as intended.No further investigation will be conducted.

• Brand Name: PROPAQ CS 246
• Type of Device: PROPAQ CS 246
• Manufacturer (Section D): WELCH ALLYN; 4341 state street road; p.o. box 220; skaneateles falls NY 13153 0220
• Manufacturer (Section G): WELCH ALLYN; 4341 state street road; p.o. box 220; skaneateles falls NY 13153 0220
• Manufacturer Contact: amy forbes ; 4341 state street road; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156852597
• MDR Report Key: 5828847
• MDR Text Key: 51930711
• Report Number: 1316463-2016-00011
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K910882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2016

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: Health Professional
• Device Model Number: 246CS/GERMAN/SPN/WAFN/IEC/PLUGC
• Device Catalogue Number: 9001-069934
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1