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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 Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Devilbiss healthcare received a complaint of "not working, will not turn on at all" 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 low suction condition was battery low voltage.The unit was repaired and returned to the customer.
 
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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.
port washington, NY 11050
5169984600
MDR Report Key15339436
MDR Text Key304806488
Report Number2515872-2022-00167
Device Sequence Number1
Product Code JCX
UDI-Device Identifier00885304002369
UDI-Public885304002369
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 09/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number7305P-D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2022
Date Manufacturer Received04/29/2022
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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