MAUDE Adverse Event Report: WELCH ALLYN PROTOCOL, INC. MICROPAG 408

Model Number MICROPAQ 408

Device Problem Programming Issue (3014)

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

Event Date 05/12/2014

Event Type  malfunction  

Event Description

The customer reported that they have two micropaqs that have the same serial number.One just came back from repair.Customer says it was sent in as sn (b)(4), but came back as (b)(4).They already have a device that has that (b)(4) serial number.Customer would like the device to be reprogrammed to be (b)(4).There was no report of any pt harm as a result of the reported event.

Manufacturer Narrative

We are reporting this complaint in an abundance of caution, pending further investigation.The device eval is not yet complete.A f/u report will be submitted when the eval is complete.

• Brand Name: MICROPAG 408
• Manufacturer (Section D): WELCH ALLYN PROTOCOL, INC.; 8500 s.w. creekside place; beaverton OR 97008 710
• Manufacturer Contact: robert berry ; 8500 s.w. creekside place; beaverton, OR 97008-7107 ; 5035307500
• MDR Report Key: 3905189
• MDR Text Key: 4517397
• Report Number: 3023750-2014-00013
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/12/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: MICROPAQ 408
• Device Catalogue Number: 007-0419-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 06/11/2014
• 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