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

Model Number 1076493

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

Patient Problems Hypoventilation (1916); No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2017

Event Type  Injury  

Event Description

The manufacturer received information alleging a bipap a40 shut down with no alarms.The patient required manual ventilation until a replacement was set up.The investigation is still ongoing.A follow up report will be filed when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a bipap a40 allegedly shut down with no alarms.The patient required manual ventilation until a replacement was set up.The device was returned to the manufacturer's quality assurance laboratory for further investigation.The customer's complaint of the device shut down with no alarm on the night of (b)(6) 2017 was not confirmed.A review of the event log indicates the device was manually powered off on (b)(6) 2017 at 03:21:30 utc.The device was not powered back on until (b)(6) 2017@ 13:45:23 utc.The directview report also indicates the device was not in use on the date of the event.The device was visually inspected internally and externally by the manufacturer and found evidence of contamination throughout the device.The device was tested and was found to operate and alarm to design specifications.The manufacturer concludes the device was not in use during the reported time of the event.

• Brand Name: BIPAP A40
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS; 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: 6321675
• MDR Text Key: 67097897
• Report Number: 2518422-2017-00392
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1076493
• Device Catalogue Number: 1076493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2014
• 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: 56 YR