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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS INC. BIPAP PRO WITH BI-FLEX; VENTILATOR, NON-CONTINUOUS, RESPIRATOR
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RESPIRONICS INC. BIPAP PRO WITH BI-FLEX; VENTILATOR, NON-CONTINUOUS, RESPIRATOR Back to Search Results
Model Number DS650HS
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/16/2014
Event Type  malfunction  
Event Description
It was alleged by an end user that an ac power cord to a bi-level positive airway pressure (bipap) device sustained thermal damage while plugged in to an ac outlet.There was no report of patient harm or injury.
 
Manufacturer Narrative
The manufacturer received the bipap, heated humidifier, power supply and only partially intact ac power cord for investigation.The manufacturer confirmed that a thermal event had occurred at the male end of the ac power cord, allowing exposed wires.The power cord could not have been placed into use after the event.Because the power cord was not fully intact, no root cause could be determined, although poor physical connection between the ac power cord and ac wall outlet is likely.No further action is necessary.
 
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Brand Name
BIPAP PRO WITH BI-FLEX
Type of Device
VENTILATOR, NON-CONTINUOUS, RESPIRATOR
Manufacturer (Section D)
RESPIRONICS INC.
murrysville PA
Manufacturer Contact
roger hyde
1740 golden mile hwy.
monroeville, PA 15146
7243875690
MDR Report Key4012782
MDR Text Key4704789
Report Number2518422-2014-01085
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDS650HS
Device Catalogue NumberDS650HS
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/16/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
HEATED HUMIDIFIER, PN 1056215SN, (B)(4)
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