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

Model Number 1111143

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

Patient Problem Insufficient Information (4580)

Event Date 03/21/2023

Event Type  Death  

Event Description

The manufacturer became aware of allegation of death on bipap a40 device.The hospital sst notified philips the patient had passed away.The hospital stated there was no allegation the device contributed to death.Currently, the device has not yet returned to the manufacturer for investigation.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 the manufacturer for evaluation.

Manufacturer Narrative

It was previously reported: the manufacturer became aware of allegation of death on bipap a40 device.The hospital sst notified philips the patient had passed away.The hospital stated there was no allegation the device contributed to death.Currently, the device has not yet returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Correction to box d.: this report is being filed to correct the data that was not available at the time of the initial report.This complaint was previously filed as bipap a40 k121623.The correct product brand name is bipap a30 k113053, product fda code, sn#, model#, udi #.Box h.: manufacturer date.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP A30
• 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: 17735388
• MDR Text Key: 323263345
• Report Number: 2518422-2023-22598
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 2 Devices were Involved in the Event: 1 2

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: 1111143
• Device Catalogue Number: 1111143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death