MAUDE Adverse Event Report: WELCH ALLYN PROPAQ CS 242

Model Number 242CS

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

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

Event Date 01/07/2015

Event Type  malfunction  

Event Description

The customer reported that their propaq cs experienced an unexpected shutdown during monitoring of a patient upon initiation of a non-invasive blood pressure.There was no report of any patient harm as a result of the reported event.The customer did not provided any patient information.

Manufacturer Narrative

The monitor involved in the incident has been returned to welch allyn.The device evaluation is not yet complete.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The propaq cs monitor was returned for evaluation.Welch allyn product service confirmed the customer allegation of a device shutdown.The cause was a damaged battery.The battery was replaced and the device functioned as intended.Welch allyn will be communicating with their consignees to reaffirm following the directions for use for proper battery care.

• Brand Name: PROPAQ CS 242
• Type of Device: PROPAQ CS
• Manufacturer (Section D): WELCH ALLYN; 4341 state st. rd.; p.o. box 220; 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: 4491571
• MDR Text Key: 5345302
• Report Number: 1316463-2015-00007
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2015

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: 242CS
• Device Catalogue Number: 9001-008152
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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