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

Model Number PM65

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 296505414
• Report Number: 2523148-2022-00001
• Device Sequence Number: 1
• Product Code: BTA
• UDI-Device Identifier: 00855887006580
• UDI-Public: 00855887006580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PM65
• Device Catalogue Number: PM65
• Device Lot Number: 041112
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2012
• 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