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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

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RESPIRONICS, INC. RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60 V60PLUS VENTILATOR
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2023
Event Type  malfunction  
Event Description
Philips received a complaint by the customer on the v60 indicating that after the device was turned on, a 1007 "machine and proximal pressure sensors failed" error occasionally appeared, and the data acquisition (da) printed circuit board assembly (pcba) needed to be replaced.It was reported that there was no patient involvement at the time the issue was discovered.The customer called technical support to report that the data acquisition (da) printed circuit board assembly (pcba) needed to be replaced.Per good faith effort (gfe) response, the authorized service provider (asp) engineer confirmed that after the device was turned on, a 1007 "machine and proximal pressure sensors failed" error occasionally appeared.The investigation is ongoing.
 
Manufacturer Narrative
The customer called technical support to report that the data acquisition (da) printed circuit board assembly (pcba) needed to be replaced.Per good faith effort (gfe) response, the authorized service provider (asp) engineer confirmed that after the device was turned on, a 1007 "machine and proximal pressure sensors failed" error occasionally appeared.The asp engineer found that the da pcba was faulty and stated that the equipment department of the hospital replaced the da pcba to resolve the issue.The device passed the required performance verification tests per philips standard and was returned to service.The investigation concludes that no further action is required at this time.
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, 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 Key18564454
MDR Text Key333494965
Report Number2518422-2024-03952
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
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 Operator Health Professional
Device Model NumberV60 V60PLUS VENTILATOR
Device Catalogue Number1076716
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/09/2024
Initial Date FDA Received01/23/2024
Supplement Dates Manufacturer Received01/28/2024
Supplement Dates FDA Received02/05/2024
Date Device Manufactured06/07/2016
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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