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

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.

• Brand Name: BIPAP A40
• Type of Device: VENTILATOR, 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 Key: 5918046
• MDR Text Key: 54323089
• Report Number: 2518422-2016-03635
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (Y/N): N
• Reporter Country Code: FR
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• 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 Received: 08/31/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 1111175
• Device Catalogue Number: 1111175
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown