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

Model Number 7305P-D

Device Problem Decrease in Pressure (1490)

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

Event Type  malfunction  

Event Description

Devilbiss healthcare received a complaint of "low suction" involving a devilbiss suction device.There was no report or evidence of illness, injury or medical treatment associated with the complaint.The unit was returned to devilbiss for evaluation.The root cause of the failure mode was back-suction of evacuated contents into the unit, rendering it unrepairable.This condition is the result of failing to operate the device as intended.

• 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: 15233475
• MDR Text Key: 304806412
• Report Number: 2515872-2022-00147
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00885304002369
• UDI-Public: 00885304002369
• 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: Inspection
• Type of Report: Initial
• Report Date: 08/16/2022

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: 7305P-D
• Device Catalogue Number: 7305P-D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2018
• 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