MAUDE Adverse Event Report: WELCH ALLYN, INC. SURETEMP PLUS; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 692

Device Problem Difficult to Remove (1528)

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

Event Date 09/04/2012

Event Type  No Answer Provided  

Event Description

The temp probe is difficult to remove and replace due to the plastic cover.It is very difficult to unlatch it from its position.

• Brand Name: SURETEMP PLUS
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state st rd; skaneateles falls NY 13153
• MDR Report Key: 4188136
• MDR Text Key: 5098726
• Report Number: 4188136
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/20/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Model Number: 692
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2014
• Patient Sequence Number: 1