MAUDE Adverse Event Report: WELCH ALLYN, INC. PROPAQ CS 242

Model Number PROPAQ 242CS

Device Problems Loss of Power (1475); Battery Problem (2885)

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

Event Date 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

Welch allyn is reporting this in an abundance of caution for a potential unexpected device shutdown.A follow-up report will be submitted when eval of the device is complete.

Event Description

The welch allyn customer reported that their propaq monitor turned off during use, and the "battery would not load".There was no report of any pt harm as a result of the reported event.

Manufacturer Narrative

The device was received for evaluation, and was assessed by welch allyn product service and welch allyn engineering.No systemic issue was identified as a result of this investigation.A loose fuse cap prevented the device from charging properly.Once the fuse cap was seated, the device charged as intended.No design issue or component issue was identified with the device.A review of the device directions for use (dfu) identified that instruction is provided to the user for checking the fuse and fuse cap in the event of failure to charge the device, and that the dfu provides instructions for fuse replacement.Based on this information, no further action is required.

• Brand Name: PROPAQ CS 242
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state st. rd.; skaneateles falls NY 13153
• Manufacturer (Section G): WELCH ALLYN; 4341 state street road; p.o. box 220; skaneateles falls NY 13153 0220
• Manufacturer Contact: lauren neubauer ; 4341 state street road; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156853674
• MDR Report Key: 4954229
• MDR Text Key: 22979618
• Report Number: 1316463-2015-00028
• 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: Other
• Type of Report: Followup
• Report Date: 06/25/2015

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: PROPAQ 242CS
• Device Catalogue Number: 9001-004474
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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