MAUDE Adverse Event Report: WELCH ALLYN PROPAQ CS 242

Model Number PROPAQ 242CS

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

Welch allyn is reporting this in an abundance of caution for a potential unexpected shutdown without alarms or alerts.A follow-up report will be submitted when evaluation of the device is complete.

Event Description

The welch allyn customer reported that their propaq monitor is switching off when starting blood pressure measurement with no alarms or alerts.There was no report of any patient harm as a result of the reported event.

Manufacturer Narrative

Welch allyn service was unable to confirm the customer's allegation of an unexpected shutdown.The device was investigated and no problem was found.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 242
• Manufacturer (Section D): WELCH ALLYN; 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: 5008533
• MDR Text Key: 24401605
• Report Number: 1316463-2015-00035
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• PMA/PMN Number: K012451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/22/2015

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 242CS
• Device Catalogue Number: PROPAQ 242/CS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2003
• 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