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

Model Number 7314P-D

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Devilbiss healthcare was notified of an incident involving a suction unit by a distributor, who stated that the unit had "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 the minimum specification.The root cause was determined to be an umbrella-style check valve that had dislodged from the compressor cylinder and a loose manifold.Devilbiss has an active capa associated with valve/cylinder complaints.

• Brand Name: DEVILBISS
• Type of Device: 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: 15986398
• MDR Text Key: 305510970
• Report Number: 2515872-2022-00229
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00885304000327
• UDI-Public: 885304000327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 7314P-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1