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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

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RESPIRONICS CALIFORNIA, INC V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.(b)(6)2020.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Event Description
The customer reported the following errors: 35 v fault, ventilator restarted due to anomalies detected during operation, backup alarm failed, 35 v supply failed, and auxiliary alarm supply failed.There was no patient involvement.
 
Manufacturer Narrative
The device was not being used for medical treatment; no further details were provided regarding the event.No patient or user harm was reported.
 
Manufacturer Narrative
The unit was in clinical use at the time of the event.No patient or user harm reported.Customer reported a code of 1104-backup alarm failed.During technical assistance, the remote service engineer (rse) verified with customer that the following codes were logged (codes 1101-ventilator restarted due to anomalies detected during operation, 1104-backup alarm failed, 111b-35v supply failed, 1115-auxilliary alarm supply failed).The customer was then advised to replace the cpu board (p/n 1123932 / 453561535741 (software 2.10)).The rse also spoke with the customer regarding the serial number and power on hrs reload, while using a teraterm.It was also noted that the rse was advised to call back for option codes.It was reported that the cpu board was replaced, and the customer was provided with option codes for cflex, avaps, and ramp.Multiple good faith efforts (gfe) were performed to obtain information regarding the the operational status of the device; however, no response was provided.
 
Manufacturer Narrative
H11:h6: patient information: the device was being used for medical treatment; no further details were provided regarding the event.No patient or user harm was reported.
 
Manufacturer Narrative
The device was being used for medical treatment, and the patient was transferred to a different ventilator; no further details were provided regarding the event.No patient or user harm was reported.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
carlsbad CA
Manufacturer Contact
bill cole
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key11022847
MDR Text Key222320366
Report Number2031642-2020-04598
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/22/2021
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/19/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received08/04/2021
09/08/2021
09/22/2021
10/27/2021
Supplement Dates FDA Received09/03/2021
09/08/2021
10/20/2021
11/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/29/2012
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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