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

Model Number	IRC5PO2V
Medical Device Problem Codes	Overheating of Device (1437); Explosion (4006)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The allegation that the product tank cap released sharp metal pieces is inaccurate; the product tank cap is composed of nylon (plastic), not metal.The concentrator was returned to invacare and was evaluated.It was confirmed that the unit exhibited damage to the product tank and shroud, as was alleged.The product tank was returned detached from the concentrator assembly and the tank cap was broken into a number of small fragments.The shroud hinges were broken, the sound box was visibly bent, and the control panel was cracked above the intended location of the product tank.All of this indicated the product tank experienced an over-pressurization event.However, it could not be determined with certainty whether any components escaped the shroud during the event.Additionally, the concentrator's pe valve tubing was damaged and discolored in the vicinity of the left sieve bed cap.This failure mode has been previously identified and investigated.The investigation activities concluded that the failure is unlikely to occur when the system is operating under normal conditions or a single fault condition.Rather, the system likely has to experience multiple faults to result in the failure observed.Even though the failure is unlikely to occur, the concentrator's components are being updated to prevent potential recurrence of this issue.
Event or Problem Description
The provider reported that the irc5po2v concentrator made a loud noise, and it was discovered that the product tank seal had burst and punctured through the top shroud, which damaged the hour meter and sound box.He alleged that the metal casing of the product tank cap shot through the top shroud, sending sharp metal into the room.The provider advised that the unit is a rental and was in a patient's home when the incident occurred, but no injuries or property damage resulted from the event.

• 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: 8273945
• Report Number: 1031452-2019-00002
• Device Sequence Number: 1306915
• 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
• Report Date (Section B): 12/26/2018

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: 01/09/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1