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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number V200
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/05/2023
Event Type  malfunction  
Event Description
Philips received a complaint from the customer reporting a blurred screen on the esprit v1000 ventilator.The device was not in clinical use.There was no report of harm.Investigation ongoing.
 
Manufacturer Narrative
H10: the customer declined the proposal for corrective services.Therefore, no further investigation for this event is possible at this time.If additional information is received the complaint file will be reopened.
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
kimberly shelly
1001 murry ridge lane
murrysville, PA 15668
7247330200
MDR Report Key17735520
MDR Text Key323265736
Report Number2518422-2023-22606
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110083
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberV200
Device Catalogue Number701-01000-00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/27/2023
Date Device Manufactured06/18/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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