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

Model Number 1111177

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Intermittent Loss of Power (4016)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 09/18/2018

Event Type  Injury  

Event Description

The manufacturer received information alleging a patient cardiac arrested while using a bipap a40.The patient was taken to the hospital by ambulance and was intubated and placed on a ventilator.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be submitted when the manufacturer has completed the investigation.

Manufacturer Narrative

The manufacturer previously reported a patient allegedly had a cardiac arrest while using a bipap a40.The patient was taken to the hospital by ambulance and was intubated and placed on a ventilator.The device was returned to the manufacturer's quality assurance laboratory for further investigation.The manufacturer did not duplicate the reported event of the device alarming.The device's event log was reviewed by the manufacturer and found the reported event was logged on the date of the event, 09/19/2018.The manufacturer confirmed the event was likely caused by the dc power supply output connector was not being fully mated to the bipap dc input connector.The dc output connector of the dc supply was found to be bent/mishapened due to being exposed to forces beyond its intended design.The event log indicates all alarms were acknowledged by the user.

• 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: 7905894
• MDR Text Key: 121597467
• Report Number: 2518422-2018-02269
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1111177
• Device Catalogue Number: 1111177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• 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
• Patient Age: 2 YR