MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE PERFECTO2 V OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number	IRC5PO2V
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The provider was contacted for additional information.He advised that he was not directly involved with the patient, and he was not made aware of the event until 1-2 weeks after it occurred, so he had limited information.He advised that the concentrator is a rental unit.He stated that the patient called after hours and left a message stating that the concentrator made a loud "boom" and started smoking badly.The provider was not aware if the patient had just turned on the unit or if it had been running some time before it started smoking.He was also not aware of the duration of the smoke or if the concentrator produced any alarms, and he did not know where the concentrator was located when the incident occurred.He stated that there were no patient injuries reported as a result of the event.He advised that a technician went to the patient's home and discovered that the cabinet filter door was melted, so he provided the patient with a replacement unit and brought back the damaged unit.The provider stated that he examined the device and observed that the cabinet filter and cabinet door were burned through.Also, there was sieve dust around the inlet filter.The provider sent photographs which confirmed the alleged issue.The photographs showed that a portion of the cabinet filter is missing, and in the same area there is discoloration/deformation to the cabinet door.Additionally, there is discoloration/deformation to the rear shroud near the inlet filter, and there is sieve material present at the base of the inlet filter.The evidence observed in the photographs, along with the reported issue of the unit smoking, indicates that an overheating event occurred.The provider was issued a replacement irc5po2v unit, and the damaged device was returned to invacare.Once the results of the evaluation are available, a supplemental record will be filed.
Event or Problem Description
A repair center technician reported that the provider sent the irc5po2v concentrator to them, stating that there was smoke coming from the unit.The repair technician advised that when he took off the cabinet filter door, there was a hole in the plastic that was melted.
Additional Manufacturer Narrative
Through visual inspection of the returned concentrator, it was determined that there was damage consistent with applied heat.The heat appeared to cause damage to the left sieve bed cap, pe valve tubing, check valve tubing, cabinet door, and gross particle filter.This failure mode has been previously identified and investigated.The investigation activities determined that when the system is operating under normal conditions or a single fault condition, it is unlikely to produce temperatures that would result in a combustion event.This indicates that the system would likely have to experience a multiple point failure to produce a temperature capable of igniting the materials within the concentrator.It was identified that improvements to system elements, including the elimination of debris and lubricant within the system, could be made to positively impact the oxygen compatibility of the system.These improvements are in the process of being implemented.
Event or Problem Description
A repair center technician reported that the provider sent the irc5po2v concentrator to them, stating that there was smoke coming from the unit.The repair technician advised that when he took off the cabinet filter door, there was a hole in the plastic that was melted.

• Brand Name: INVACARE PERFECTO2 V OXYGEN CONCENTRATOR
• Common Device Name: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• MDR Report Key: 8141653
• Report Number: 1031452-2018-00016
• Device Sequence Number: 18886313
• Product Code: CAW
• UDI-Device Identifier: 00841447100010
• UDI-Public: 00841447100010
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IRC5PO2V
• Device Catalogue Number: IRC5PO2V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1