MAUDE Adverse Event Report: WELCH ALLYN PROPAQ LT 802

Model Number PROPAQ LT 802

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

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

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

Welch allyn is reporting in an abundance of caution.Our evaluation of this incident is not yet complete.A follow-up report will be submitted when the evaluation is compete.

Event Description

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

Manufacturer Narrative

The device was returned and evaluated by (b)(4) product service.(b)(4) product service confirmed the allegation of device shutting down without alarms or alerts.The device was evaluated by (b)(4) engineering dept.The cause was determined to be a main pcba component failure.The device was scrapped by (b)(4) at the customer's request.No further investigation will be conducted.

• Brand Name: PROPAQ LT 802
• Type of Device: PROPAQ LT 802
• 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: 5138389
• MDR Text Key: 28106572
• Report Number: 1316463-2015-00046
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K012451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/11/2015

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 LT 802
• Device Catalogue Number: 802LT0N-UL2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2008
• 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