MAUDE Adverse Event Report: WELCH ALLYN, INC. PROPAQ ENCORE106EL

Model Number 106EL

Device Problems Device Expiration Issue (1216); Loss of Power (1475); Device Issue (2379)

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

Event Date 01/12/2015

Event Type  malfunction  

Event Description

The customer stated the battery on the transport monitor failed 45 minutes into a patient transfer.According to the staff, the monitor just immediately stopped working with no prior warning to loss of power".Customer stated the battery was found to be over four years old.There was no report of any patient harm as a result of the reported event.

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 f/u report will be submitted upon receipt of the device and when the evaluation is complete.

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 ENCORE106EL
• Type of Device: PROPAQ ENCORE
• 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: amy forbes ; 4341 state street road; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156852597
• MDR Report Key: 4645693
• MDR Text Key: 5685589
• Report Number: 1316463-2015-00015
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K910882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

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: 106EL
• Device Catalogue Number: 9002-019935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2015
• Initial Date FDA Received: 03/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2009
• 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