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

Model Number R1076495

Device Problem Unexpected Shutdown (4019)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2016

Event Type  Injury  

Event Description

The manufacturer received information alleging a ventilator inoperative condition occurred.The device was replaced.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was duplicated.The device's valve was replaced to address the issue.The replaced part was received at the philips investigation lab (pil) but the reported issue was not duplicated during testing.The valve assembly was installed and operated on a testing device for an extended period of time with no indication of a failure.The valve assembly did show evidence of contaminants which may have contributed to the reported event.

Manufacturer Narrative

The manufacturer previously reported information alleging a ventilator inoperative condition occurred.The device was replaced.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was duplicated.The device's valve was replaced to address the issue.The replaced part was received at the philips investigation lab (pil) but the reported issue was not duplicated during testing.The valve assembly was installed and operated on a testing device for an extended period of time with no indication of a failure.The valve assembly did show evidence of contaminants which may have contributed to the reported event.Corrections have been made as follows: section b.Adverse event/product problem changed to "both", outcomes attributed to ae changed to "other", and section h.Type of reported complaint changed to "serious injury." coding has been updated accordingly.After further review, this report will now be filed as an adverse event.The manufacturer received information that the patient desaturated and an alarm was activated.The device was turned on by a nurse, but the alarm occurred again.The patient was disconnected from the device and the device was replaced.There was no report of the patient suffering any health hazard.

• 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: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18758270
• MDR Text Key: 336228453
• Report Number: 2518422-2024-09146
• 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: Other
• Type of Report: Initial,Followup

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?: Yes
• Device Operator: Health Professional
• Device Model Number: R1076495
• Device Catalogue Number: R1076495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2016
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 08/27/2016
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Sex: Female