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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 PLUS
Device Problem Failure to Run on Battery (1466)
Patient Problem No Patient Involvement (2645)
Event Date 02/16/2021
Event Type  malfunction  
Manufacturer Narrative
Note: 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 pr# (b)(4).
 
Event Description
The customer reported problem in the ventilator belonging to the intensive care unit, the battery has depleted.It only works when plugged in to the main electrical power.Not in use, no patient or user harm reported.
 
Manufacturer Narrative
B4:(b)(6)2021 the customer confirmed the reported failure.The customer replaced the battery to resolve the issue.The unit was tested and it was returned to service.No part is returned, the customer recycled the battery.
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
MDR Report Key11418763
MDR Text Key235017154
Report Number2031642-2021-03002
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
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 PLUS
Device Catalogue Number1137276
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date02/16/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/05/2021
Supplement Dates Manufacturer Received05/07/2021
Supplement Dates FDA Received05/18/2021
Date Device Manufactured08/22/2020
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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