MAUDE Adverse Event Report: PRECISION MEDICAL INC PM4150 EASY PULSE POC

Model Number	PM4150
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User of pm4150 portable oxygen concentrator (sn (b)(4)) contacted precision medical inc on 12/10/2019 indicating the device caught fire and damaged his home.User originally claimed his house burned down.User indicated he heard a hissing noise and seen the fire.User was difficult to understand and at one point indicated something about his walls being black or to some sort.User claimed he had no insurance and was contacting precision medical inc to file a claim.User indicated the device was thrown in the trash (by who unknown).User indicated he had no report to send to precision medical inc.User did not know the name of the fire department he claimed came to his house; however provided #38 & #22.Precision medical inc contacted medmarc insurance company to investigate the validity of the claim.As of 12/13/2019; medmarc insurance company was able to contact the fire company which confirmed there was no confirmed fires at the address supplied by the user.Medmarc was unable to reach the user via telephone with numerous calls and voice-mails.Medmarc insurance company is sending a letter to the user to obtain additional information and determine the validity of the claim.
Event or Problem Description
End user claims pm4150 portable oxygen concentrator caused fire damage to home.
Additional Manufacturer Narrative
Follow-up report "(b)(6) fire rescue department - afrd# (b)(4)" received from medmarc insurance company attached.Unknown if precision medical pm4150 portable oxygen concentrator was involved? report indicates "oxygen machine" user indicated as noted in previous submission the device was thrown in the trash (by who unknown)."atlanta fire rescue department - afrd#: (b)(4)" report indicates the following: after a systematic review of the fire scene and any avilable documents, photos, videos or statements, it is my conclusion that the fire orginated in the bedroom due to unknown circumstances.I have two hypotheses for this incident that i unable to confirm.1.There was a mechnical or electrical failure in the oxygen machine that ignited the combustibles in the room.2.Mr.Grimes was smoking and was carless with one of his cigarettes causing the combustibles in the room to ignite.At this time, i am unable to confirm either of my hypotheses and will be classifying this fire as undetermined.- attachment: [(b)(6) fire & rescue dept incident report (b)(4)).Pdf].
Event or Problem Description
End user claims pm4150 portable oxygen concentrator caused fire damage to home unknown if precision medical pm4150 portable oxygen concentrator given by patient was involved.

• Brand Name: PM4150 EASY PULSE POC
• Common Device Name: PM4150 EASY PULSE POC
• Manufacturer (Section D): PRECISION MEDICAL INC; 300 held drive; northampton PA 18067
• MDR Report Key: 9536069
• Report Number: 2523148-2019-00003
• Device Sequence Number: 11351205
• Product Code: CAW
• UDI-Device Identifier: 00855887006078
• UDI-Public: 00855887006078
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K103563
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2019

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: No Information
• Device Model Number: PM4150
• Device Catalogue Number: PM4150
• Device Lot Number: 111918
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention