MAUDE Adverse Event Report: LONG BEACH MEMORIAL MEDICAL CENTER EASY GO VAC; EASY GO VAC ASPIRATOR

Model Number	PM65
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 06/27/2022 precision medical inc was notified that there was an apparent fire with an incubator set-up which included the pm65 aspirator.The device was manufactured over 10 years ago which is past the expected lifetime for the device.Precision medical inc received the pm65 aspirator back for evaluation which contained apparent smog/soot around the external charging connector.Charger/power supply was not returned for investigation.It is unknown if the device has ever been serviced; however the battery was replaced by the customer as it was not a precision medical supplied battery.Review of maude database for product code (bta) from 2011 to present indicates no trending of fires.Internal complaint data which indicates no issues related to fire for the pm65 since the release of the device on 04/01/1998.Approximately (b)(4) devices shipped with no complaints related to fires.Origin of the fire is most likely the external charging connector as it has the darkest most concerted charr on the device; however, the power supply and photos of the power source were not provided; therefore no decisive conclusion of source can be confirmed.Should additional information become available a follow-up report will be submitted.
Event or Problem Description
Customer stated when staff came in the morning they saw soot from an apparent small fire covering most of the equipment on the incubator.There was no fire when they came in that morning just the black soot.The incident stated happened overnight when no one was around.Precision medical inc pm65 aspirator was part of the equipment on the incubator.

• Brand Name: EASY GO VAC
• Common Device Name: EASY GO VAC ASPIRATOR
• Manufacturer (Section D): LONG BEACH MEMORIAL MEDICAL CENTER; 2801 atlantic avenue; long beach CA 90806
• Manufacturer (Section G): PRECISION MEDICAL INC; 300 held drive; northammpton PA 18067
• Manufacturer Contact: brian klotz ; 300 held drive; northampton, PA 18067 ; 6102626090
• MDR Report Key: 15095456
• Report Number: 2523148-2022-00001
• Device Sequence Number: 5234755
• Product Code: BTA
• UDI-Device Identifier: 00855887006580
• UDI-Public: 00855887006580
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K971749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PM65
• Device Catalogue Number: PM65
• Device Lot Number: 041112
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown