MAUDE Adverse Event Report: RESPIRONICS, INC. SIMPLYGO MINI; GENERATOR, OXYGEN, PORTABLE

Model Number	1113605
Medical Device Problem Codes	Device Emits Odor (1425); Smoking (1585); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a simplygo mini portable oxygen concentrator had a burning smell, a shorted input power system, and smoke came out of the back of the concentrator while it was charging.There was no report of serious patient harm or injury.There was no report of medical intervention.The device was returned to the manufacturer for evaluation.The product investigation lab confirmed the main pca (components c128) circuit trace open condition which resulted from a "short to ground," appears to be an eos/esd event.Furthermore, the thermally stressed component vented, and no further damage was confirmed.This thermal event is isolated to the printed circuit assembly substrate (ground) trace area and components.Component venting is isolated to the component and solder lands only.No evidence of creeping is found.Indicative of compressor in need of replacement/overstressed from duty cycle/worn parts/in need of maintenance.Upon visual inspection, the unit appears to have been dropped/neglected/tampered.There are multiple points of physical damage.The main pca appears to have taken a voltage spike or eos/esd.Components c128 (power inlet choke) have partially separated itself away from the pca solder lands.There is black carbon build up around the main pca c128 solder lands.Components c128, short to ground originate from the power inlet side/circuit.This fault/failure mode indicative of inlet dc power surge/eos/esd or even from physical stress from a dropped condition.The product investigation lab can confirm the main pca (component c128 dc power inlet) circuit trace open condition that resulted from a "short to ground," appears to be an eos/esd event.Furthermore, the thermally stressed component separated from the solder lands and self-extinguished.Materials were scrapped/recycled as appropriate.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.

• Brand Name: SIMPLYGO MINI
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 20835754
• Report Number: 2518422-2024-104965
• Device Sequence Number: 4070105
• Product Code: CAW
• UDI-Device Identifier: 00606959032439
• UDI-Public: (01)00606959032439
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: Health Professional
• Device Model Number: 1113605
• Device Catalogue Number: 1113605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2019
• 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 Age: 82 YR
• Patient Sex: Male