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

Model Number 1111170

Device Problems Loss of Power (1475); Device Operational Issue (2914)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 07/08/2015

Event Type  Injury  

Event Description

The manufacturer received information alleging a bipap a40 stopped working while using an external battery after a reported blackout occurred in a hospital.The patient was manually ventilated and placed on another device.The device has yet to be evaluated by the manufacturer.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer has completed the investigation of a bipap a40 that allegedly stopped working while using an external battery after a reported blackout occurred in a hospital.The patient was manually ventilated and placed on another device.The device was returned to the manufacturer for evaluation.The customer's complaint was not confirmed.The device's error log was reviewed by the manufacturer and found no error codes indicative of a failure.The device was tested with ac and dc power and the manufacturer confirms the device operates to design specifications on both power sources.The manufacturer concludes the device operated to design specifications.The customer's complaint was not confirmed by the manufacturer.

• 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, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: wilfredo alvarez ; 312 alvin drive; new kensington, PA 15068 ; 7243349303
• MDR Report Key: 4953334
• MDR Text Key: 6634023
• Report Number: 2518422-2015-02254
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1111170
• Device Catalogue Number: 1111170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4 YR