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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 7305D-D-EXF
Device Problem Suction Problem (2170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Devilbiss healthcare was notified by an oxygen supplier of a complaint involving a devilbiss suction unit stating that the unit is "not suctioning properly." there was no report or evidence of illness, injury or medical treatment associated with the complaint.The device was returned for evaluation.Devilbiss evaluated the unit and determined that the primary cause was an umbrella valve being dislodged from the compressor cylinder, manifold, broken/damaged suction gauge.Devilbiss has an active capa associated with cylinder/valve 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 Key15234901
MDR Text Key304806341
Report Number2515872-2022-00138
Device Sequence Number1
Product Code JCX
UDI-Device Identifier00885304008866
UDI-Public00885304008866
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
Remedial Action Repair
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 Number7305D-D-EXF
Device Catalogue Number7305D-D-EXF
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2022
Initial Date Manufacturer Received 06/17/2022
Initial Date FDA Received08/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2020
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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