MAUDE Adverse Event Report: WELCH ALLYN PROPAQ ENCORE 206/EL

Model Number ENCORE 206/EL

Device Problems Device Alarm System (1012); Loss of Power (1475); Device Issue (2379)

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

Event Date 08/12/2015

Event Type  malfunction  

Manufacturer Narrative

Welch allyn is reporting this in an abundance of caution for a potential unexpected device shutdown.The unit has not been returned to welch allyn at this time.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that the device would shut down without alarms or alerts when attempting a print function snapshot.

Manufacturer Narrative

The device was not returned to welch allyn for evaluation.Troubleshooting with the customer confirmed that the device had an aged battery.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 ENCORE 206/EL
• Type of Device: PROPAQ ENCORE 206/EL
• 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: 5065244
• MDR Text Key: 25934280
• Report Number: 1316463-2015-00041
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/12/2015

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: Biomedical Engineer
• Device Model Number: ENCORE 206/EL
• Device Catalogue Number: ENCORE 206/EL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2015
• Initial Date FDA Received: 09/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2008
• 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