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

Model Number	7305P-D-EXF
Medical Device Problem Code	Suction Failure (4039)
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 a suction unit by a distributor, who stated that the unit "would not provide 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 the minimum specification.The root cause was determined to be a back suction of fluid into the motor of the unit.

• 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: jillian forster ; 99 seaview blvd; ste 210; port washington, NY 11050 ; 5169984600
• MDR Report Key: 15986765
• Report Number: 2515872-2022-00227
• Device Sequence Number: 6209255
• Product Code: JCX
• UDI-Device Identifier: 00885304008873
• UDI-Public: 885304008873
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 12/15/2022

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: 7305P-D-EXF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown