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U.S. Department of Health and Human Services

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

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RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60
Device Problem Inadequate User Interface (2958)
Patient Problem No Patient Involvement (2645)
Event Date 02/16/2021
Event Type  malfunction  
Manufacturer Narrative
We have not completed our investigation of this event.We will file a follow-up report at the completion of the investigation.Internal cross reference: complaint (b)(4).
 
Event Description
It was reported to philips that the device had error 1105 (alarm led) in the event log, and the alarm led illuminated red.The device was not in clinical use at the time of the event.There was no report of patient or user harm.The customer was given a quote for the part number and pricing for a replacement power switch overlay.
 
Manufacturer Narrative
G4:10jun2021.B4:30jun2021.The customer ordered a replacement power switch overlay to be replaced onsite by the customer.No onsite service was requested, and the case was closed.A supplemental report will be submitted if new information is received.
 
Manufacturer Narrative
B4:07sep2021.It is unknown if the device was in clinical use at the time of the event.The customer could not be reached for additional information regarding how the device was being used when the problem was observed.There was no report of patient or user harm.No part was received for evaluation.Previous investigations have shown that excessive engagement or pressure contact over the light emitting diode (led) while attempting to engage the switch due to the proximity of the led to the switch may cause a separation of the led to the encapsulant.This is subjective to the operator of the equipment which is why this is not a universal or catastrophic failure of all units.
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
MDR Report Key11418761
MDR Text Key234975412
Report Number2031642-2021-03003
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838009868
UDI-Public00884838009868
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,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
Device Catalogue Number1053615
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2021
Distributor Facility Aware Date02/16/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/05/2021
Supplement Dates Manufacturer Received06/10/2021
08/13/2021
Supplement Dates FDA Received06/30/2021
09/07/2021
Date Device Manufactured06/16/2010
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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