MAUDE Adverse Event Report: ACCUTRON, INC. ULTRA PC% PACKAGE B; GAS MACHINE FOR ANESTHESIA

Model Number	31975
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident was reported to the manufacturer by their distributor, patterson companies' field technician.The incident occurred in the dental operatory room while the o2 regulator equipment was in use on a patient.The dentist reported that he was working with a patient when he reached to increase the oxygen when the regulator exploded, injuring his hand.The unit smoked for a period of time and everyone in the office exited the area.There was no harm to the patient or any other worker in the office.No additional medical treatment was sought by the dentist.He reported self-treatment of the affected hand.There was no other equipment involved in the incident.It has been reported that this unit is an older model (manufactured in 1998) and out of warranty.There are no service records on the affected unit going back 4+ years according to the manufacturer and the distributor's records.It was also reported by a service technician who examined the affected unit after the incident that there was evidence that the manifold had previously been tampered with.A full investigation of the returned unit is currently underway.This complaint will continue to be maintained in the accutron/crosstex complaint system.
Event or Problem Description
An anesthesia gas-machine flowmeter and 4 cylinder portable system were in use during a dental procedure.The dentist operating the machine experienced injuries to the hand when the o2 regulator portion of the 4 cylinder portable system exploded.No other patients or staff members were affected by this incident.

• Brand Name: ULTRA PC% PACKAGE B
• Common Device Name: GAS MACHINE FOR ANESTHESIA
• Manufacturer (Section D): ACCUTRON, INC.; 1733 west parkside ln; pheonix AZ 85027
• MDR Report Key: 6023327
• Report Number: 2020813-2016-00001
• Device Sequence Number: 270885
• Product Code: BSZ
• UDI-Device Identifier: 00813830022469
• UDI-Public: 00813830022469
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K970163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/12/2016

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
• Operator of Device: Physician
• Device Model Number: 31975
• Device Catalogue Number: 36100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 10/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1