MAUDE Adverse Event Report: WELCH ALLYN PROPAQ ENCORE

Model Number ENCORE 202/EL

Device Problems Loss of Power (1475); Device Operational Issue (2914)

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

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is not yet complete.A follow-up report will be submitted when the evaluation is complete.

Event Description

Welch allyn received a complaint from a welch allyn customer stating that their propaq encore would shut during use without warning.There was no death/injury associated with this complaint.The customer did not provide any patient information.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

Welch allyn product service was unable to confirm the customer complaint of an unexpected shutdown due to fuse blowing.Based on the investigation and troubleshooting performed by welch allyn engineering, damage to the front housing was found.The damage to the front housing likely caused the bracket to contact the digital board, thus causing the main fuse to blow.The device was repaired and returned to the customer.The device is working as intended.No further investigation will be conducted.

• Brand Name: PROPAQ ENCORE
• Type of Device: PROPAQ ENCORE
• 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: 5460686
• MDR Text Key: 39475744
• Report Number: 1316463-2016-00008
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/12/2016

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: Biomedical Engineer
• Device Model Number: ENCORE 202/EL
• Device Catalogue Number: ENCORE 202/EL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/1997
• 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