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

Model Number R1111177

Device Problem Circuit Failure (1089)

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

Event Date 07/24/2017

Event Type  Injury  

Event Description

The manufacturer received information alleging a ventilator inoperative condition occurred.The device was restarted, and the ventilator inoperative alarm was immediately activated.A sales rep visited the site, confirmed the unit was inoperative and replaced the unit.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the ventilator inoperative alarm was confirmed.The device¿s main board was replaced to address the issue.

Manufacturer Narrative

The manufacturer previously reported information in reference to a ventilator inoperative condition.The device was restarted, and the ventilator inoperative alarm was immediately activated.A sales rep visited the site, confirmed the unit was inoperative and replaced the unit.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation and the ventilator inoperative alarm was confirmed.The device¿s main board was replaced to address the issue.A pms clinical expert review made a determination based on information available at the time of this review, that the allegations constitute a serious injury.Mdr was filing was changed from product problem to adverse event / serious injury.Patient outcome code was updated.

• Brand Name: BIPAP A40 SYSTEM
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18031673
• MDR Text Key: 326871762
• Report Number: 2518422-2023-27905
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• 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: R1111177
• Device Catalogue Number: R1111177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other