MAUDE Adverse Event Report: WELCH ALLYN PROPAQ CS 244

Model Number PROPAQ 244 CS

Device Problem Loss of Power (1475)

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

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the device evaluation is complete.

Event Description

The customer reported that their propaq cs device would shut down during use without warning.

Manufacturer Narrative

Welch allyn engineering confirmed the customer's allegation of a device shutdown.The cause was an aged battery.The device battery was found by welch allyn engineering to only have a fraction of its rated capacity.The battery was replaced and the device functioned as intended.Welch allyn will be communicating with its consignees to reaffirm following the directions for use for proper battery care.

• Brand Name: PROPAQ CS 244
• Type of Device: PROPAQ CS
• 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: 5034387
• MDR Text Key: 25132055
• Report Number: 1316463-2015-00039
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 08/25/2015

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 244 CS
• Device Catalogue Number: 9001-021594
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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