MAUDE Adverse Event Report: WELCH ALLYN, INC. 3.5V RECHARGABLE HANDLE; NONE

Model Number 71000-A

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

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

Event Date 11/11/2014

Event Type  malfunction  

Event Description

The customer placed a new battey recently purchased from a distributor in his handle that he has had since 1987/88.The handle had not been in use for 5 years.The customer plugged the handle into the wall outlet and let the room for 5 minutes.When he returned, there was smoke in the room and a blackened area around the wall outlet.The customer stated that he found the handle on the floor and the prongs still in the outlet.There was no allegation of injury.

Manufacturer Narrative

Welch allyn is reporting this event in an abundance of caution.The actual device was returned to welch allyn for review by engineering.The investigation is not yet complete.A follow-up report will be submitted when the evaluation is complete.

• Brand Name: 3.5V RECHARGABLE HANDLE
• Type of Device: NONE
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state st. rd.; skaneateles falls NY 13153
• Manufacturer Contact: pearley bhambri, director ; 4341 state st. rd.; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156852568
• MDR Report Key: 4359851
• MDR Text Key: 20125231
• Report Number: 1316463-2014-00013
• Device Sequence Number: 1
• Product Code: FCO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71000-A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1