MAUDE Adverse Event Report: AIR TECHNIQUES, INC. PERI-PRO; FILM PROCESSOR

Model Number 94000M

Device Problem Use of Device Problem (1670)

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

Event Date 08/27/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012, a psa representative (distributor) emailed air techniques to report an issue with a peri-pro.While a (b)(6) service representative was at a customer's site (lifetime dental solutions), he was asked to replaced a heater pad.After replacing the heater pad, the service rep left the room.He was then immediately alerted by the staff that the peri-pro unit was smoking.There were no injuries or health hazard reported.This peri-pro iii ((b)(4), date of manufacture 10/26/2005) was sold to (b)(6).The unit was installed in (b)(6) at lifetime dental solutions and has been in service for seven years.(b)(6) dental service technician confirmed that there were no injuries.This incident is being deemed an adulteration by the customer.This investigation was conducted from information and pictures received from (b)(6).

• Brand Name: PERI-PRO
• Type of Device: FILM PROCESSOR
• Manufacturer (Section D): AIR TECHNIQUES, INC.; melville NY
• Manufacturer Contact: 1295 walt whitman rd.; melville, NY 11747
• MDR Report Key: 4105450
• MDR Text Key: 4697857
• Report Number: 2428225-2014-00002
• Device Sequence Number: 1
• Product Code: IXW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/09/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 94000M
• Device Catalogue Number: 94000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2005
• 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
• Patient Outcome(s): Other