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

Model Number CN1111169

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 06/02/2023

Event Type  Injury  

Event Description

The manufacturer received information alleging a ventilator was stopped during use.Allegedly the patient was unconscious, and was in the icu rescue.The patient subsequently died, but the date and circumstances causing the death are unknown at this time.The device has not been returned to the manufacturer for evaluation.Good faith efforts (gfe) are being made to obtain additional information, and to have the device returned to the manufacturer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Manufacturer Narrative

The manufacturer previously received information alleging a ventilator was stopped during use.Allegedly the patient was unconscious, and was in the icu rescue.The patient subsequently died, but the date and circumstances causing the death are unknown at this time.Correction: the statement: the patient subsequently died, but the date and circumstances causing the death are unknown at this time, has been removed from the b5 describe event or problem section.Section b5, outcomes attributed to ae has been corrected to, other.The following two statements were added to the b5 statement: the patient made a complaint to the hospital.Medical intervention was not specified.The philips clinical expert made the statement about the patient dying in error.In section h the health impact grid has been corrected to serious injury/illness/impairment.

Event Description

The manufacturer received information alleging a ventilator was stopped during use.Allegedly the patient was unconscious, and was in the icu rescue.The patient made a complaint to the hospital.Medical intervention was not specified.The device has not been returned to the manufacturer for evaluation.Good faith efforts (gfe) are being made to obtain additional information, and to have the device returned to the manufacturer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer received information alleging a ventilator was stopped during use.Allegedly the patient was unconscious, and was in the icu rescue.The patient made a complaint to the hospital.Medical intervention was not specified.The device has not been returned to the manufacturer for evaluation.Good faith efforts (gfe) are being made to obtain additional information, and to have the device returned to the manufacturer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Correction: section h, type of reported complaint has been changed from death to serious injury.The originator of the record erred when creating the report.

• 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: jenn canada ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18034631
• MDR Text Key: 326886765
• Report Number: 2518422-2023-28009
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 Health Care Professional
• Type of Report: Initial,Followup,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: CN1111169
• Device Catalogue Number: CN1111169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 06/02/2023; 04/18/2024
• Supplement Dates FDA Received: 10/31/2023; 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other