MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; SUCTION UNIT

Model Number	7314P-D
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of an incident involving an oxygen concentrator by an oxygen provider, who stated that the "outer case melted." there was no report or evidence of illness, injury or medical treatment associated with the complaint.The device was returned to devilbiss for evaluation, where it was determined that the unit shows evidence of being operated in an area with a high external heat source.Drive will continue to monitor complaints for any related trends.
Event or Problem Description
Devilbiss healthcare was notified of an incident involving a suction unit by a provider, who stated the unit has "no suction." there was no report or evidence of illness, injury or medical treatment associated with the complaint.The device was returned to devilbiss for evaluation, where it was determined the unit was unable to produce vacuum pressure to specification.The root cause was the umbrella-style check valve that dislodged from the compressor cylinder.Devilbiss has a capa for the check valve complaint.

• Brand Name: DEVILBISS
• Common Device Name: SUCTION UNIT
• Manufacturer (Section D): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer (Section G): DEVILBISS HEALTHCARE LLC; 100 devilbiss drive; somerset PA 15501
• Manufacturer Contact: roberto munoz ; 100 devilbiss drive; somerset, PA 15501 ; 5169984600
• MDR Report Key: 16825852
• Report Number: 2515872-2023-00036
• Device Sequence Number: 15168181
• Product Code: JCX
• UDI-Device Identifier: 00885304000327
• UDI-Public: 885304000327
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K982304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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: Lay User/Patient
• Device Model Number: 7314P-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown