MAUDE Adverse Event Report: PRECISION MEDICAL INC EASY PULSE POC (PM4150); PORTABLE OXYGEN CONCENTRATOR

Model Number PM4150

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

The client that had this unit was mowing his yard; just like he had done many times before with the poc strapped onto his back like a backpack.Not sure how; but he said he had loosened the straps and it was resting on the back seat of the mower.It must have gotten too close to the muffler as that is what the client had stated, and it blew up & caught on fire.It scared the client to death but he was unharmed.Fortunately, he was close enough to the house that he was able to get inside and get on his concentrator.Patient notified provider ((b)(4)) of the incident.(b)(4) notified precision medical, inc.Precision medical inc issued an rga (return goods authorization) number and call tag to send the device back to precision medical.Precision medical inc was notified by the provider that they had discarded the device.Serial number provided by (b)(4) could not be physically verified by precision medical inc serial number provided by (b)(4) for model# pm4150 is 10035865 which was manufactured by precision medical in november 2017.Patient gave (b)(4) the damaged device and purchased a new device.The incident was caused by customer error.

Event Description

The client that had this unit was mowing his yard; just like he had done many times before with the poc strapped onto his back like a backpack.Not sure how; but he said he had loosened the straps and it was resting on the back seat of the mower.It must have gotten too close to the muffler as that is what the client had stated, and it blew up & caught on fire.It scared the client to death but he was unharmed.Fortunately, he was close enough to the house that he was able to get inside and get on his concentrator.

• Brand Name: EASY PULSE POC (PM4150)
• Type of Device: PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): PRECISION MEDICAL INC; 300 held drive; northampton PA 18067
• Manufacturer (Section G): PRECISION MEDICAL INC; 300 held drive; northampton PA 18067
• Manufacturer Contact: brian klotz ; 300 held drive; northampton, PA 18067 ; 6192626090
• MDR Report Key: 8983275
• MDR Text Key: 157170728
• Report Number: 2523148-2019-00001
• Device Sequence Number: 1
• Product Code: CAW
• UDI-Device Identifier: 00855887006078
• UDI-Public: 00855887006078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PM4150
• Device Catalogue Number: PM4150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2017
• 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