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

Model Number	7325P-D
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Devilbiss healthcare was notified of an incident involving a suction unit by a provider, who reported that the unit "quit suctioning, and the battery light is on, however, there is no suctioning and no sounds." there was no report or evidence of illness, injury or medical treatment associated with the complaint.The unit was discarded and could not be evaluated.

• 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: 15445787
• Report Number: 2515872-2022-00218
• Device Sequence Number: 7709155
• Product Code: JCX
• UDI-Device Identifier: 00885304032564
• UDI-Public: 00885304032564
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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
• Device Model Number: 7325P-D
• Device Catalogue Number: 7325P-D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown