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

Model Number 7314P-D

Device Problem Suction Problem (2170)

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 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 and a loose manifold.Devilbiss addressed check valve complaints via capa.

• 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: roberto munoz ; 100 devilbiss drive; somerset, PA 15501 ; 5169984600
• MDR Report Key: 17138876
• MDR Text Key: 317746493
• Report Number: 2515872-2023-00069
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• 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: 05/15/2023
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1