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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVILBISS HEALTHCARE LLC DEVILBISS; SUCTION UNIT
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DEVILBISS HEALTHCARE LLC DEVILBISS; SUCTION UNIT Back to Search Results
Model Number 7305P-D
Device Problem Suction Failure (4039)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2022
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 unit was returned and evaluated and failed initial suction testing.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.
 
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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 Key15869159
MDR Text Key304369228
Report Number2515872-2022-00192
Device Sequence Number1
Product Code JCX
UDI-Device Identifier00885304002369
UDI-Public00885304002369
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982304
Number of Events Reported1
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 11/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number7305P-D
Device Catalogue Number7305P-D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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