MAUDE Adverse Event Report: RESPIRONICS BIPAP A30-S; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number 1078223

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2017

Event Type  Injury  

Event Description

The manufacturer received information alleging a bipap a30 was not working properly.The patient was taken to the emergency room.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 a30 was allegedly not working properly.The patient was taken to the emergency room.The device was returned to the manufacturer's product investigation laboratory for further investigation.The manufacturer found evidence of tobacco/nicotine contamination throughout the device.The manufacturer found the valve contaminated preventing the valve from cycling.The manufacturer also found the blower assembly to be contaminated with tobacco/nicotine causing the impeller to rub the blower enclosure, causing the blower impeller to fracture.The device was evaluated by the manufacturer but has not yet been repaired.

• Brand Name: BIPAP A30-S
• 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: 6503420
• MDR Text Key: 73126558
• Report Number: 2518422-2017-01000
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113053
• 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: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1078223
• Device Catalogue Number: 1078223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2013
• 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 Outcome(s): Hospitalization