MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. BIPAP SYNCHRONY; MINIMAL NONINVASIVE SUPPORT

Model Number 1029756

Device Problem Mechanical Problem (1384)

Patient Problems Dyspnea (1816); Hypoxia (1918)

Event Date 02/04/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging a bipap synchrony alarmed and shut down while in patient use.The patient had dyspnea and hypoxia.The patient was placed on another ventilator and the patient recovered.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 did not report the country of occurrence in mdr 2518422-2023-06635.The country of occurrence is china.

Manufacturer Narrative

The manufacturer previously reported information alleging a bipap synchrony alarmed and shut down while in patient use.The patient had dyspnea and hypoxia.The patient was placed on another ventilator and the patient recovered.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.On the previously submitted report, the country in section f was inadvertently left blank.It is corrected on this report.After further clinical review, it has been determined, this complaint will be reported as a product problem as the events do not meet the definition of a reportable serious injury complaint per the fda regulations (21 cfr 803).Sections b and h are updated to reflect this decision.The manufacturer's investigation is ongoing.A supplemental report will be submitted when the manufacturer's investigation is complete.

• Brand Name: BIPAP SYNCHRONY
• Type of Device: MINIMAL NONINVASIVE SUPPORT
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): PHILIPS RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16543362
• MDR Text Key: 311298273
• Report Number: 2518422-2023-06635
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1029756
• Device Catalogue Number: 1029756
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/15/2023
• Supplement Dates Manufacturer Received: 03/22/2023; 03/22/2023
• Supplement Dates FDA Received: 04/10/2023; 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1