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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A40 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

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RESPIRONICS, INC. BIPAP A40 VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number 1111175
Device Problems Power Cord (497); Break (1069); Electrical /Electronic Property Problem (1198)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2016
Event Type  Malfunction  
Event Description

The manufacturer received information alleging an a40 bipap had damage to the power cord. There was no report of patient harm or injury. The investigation is still ongoing. A follow up report will be submitted when the manufacturer has completed the investigation.

 
Manufacturer Narrative

The manufacturer previously reported an a40 bipap had damage to the power cord. There was no report of patient harm or injury. The power cord and power supply were returned to the manufacturer for further investigation. The manufacturer visually inspected the ac power cord and dc power supply and observed evidence of corrosion and thermal damage to the ac inlet of the dc power supply and to the female end of the ac power cord. The ac power cord was found to have exposed leads that could come in contact with the end user. The investigation concludes the event was caused by a build-up of impurities to the contacts of the female end of the ac power cord. This caused a high current condition when the ac power cord was mated to the dc power supply. When tested, the dc power supply and ac power cord had no electrical issues. There was no evidence of an electrical failure of the device that would have resulted in the reported event. The manufacturer concludes the event was most likely caused by a build-up of impurities from an external source. The exposed lead was caused when the power cord was removed from the ac inlet of the power supply.

 
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Brand NameBIPAP A40
Type of DeviceVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
Manufacturer (Section D)
RESPIRONICS, INC.
1001 murry ridge lane
murrysville PA 15668
Manufacturer (Section G)
RESPIRONICS
1001 murry ridge lane
murrysville PA 15668
Manufacturer Contact
adam price
312 alvin drive
new kensington, PA 15068
7243349303
MDR Report Key5918046
MDR Text Key54323089
Report Number2518422-2016-03635
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK121623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 08/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1111175
Device Catalogue Number1111175
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/22/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/19/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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