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

Model Number V60

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

Patient Problem Respiratory Arrest (4461)

Event Date 10/06/2022

Event Type  Death  

Event Description

Voluntary mw5116919 report received with reports of patient death.The report submitted by deceased patient family member documents a high-risk male patient diagnosed with covid had a major decline in health and placed on v60 ventilator.The following day the patient died.Investigation is ongoing.

Manufacturer Narrative

H10: attempts have been made to try to obtain further information about this case but no further information was able to be obtained.The device is not available per the submitter and there is no information provided to substantiate the allegation that the ventilator was faulty and caused/contributed to the death.Without additional information, a causal/contributory relationship between the ventilator and the patient's death cannot be confirmed or refuted.At this time, the investigation is concluded.In the event additional information becomes available a supplemental report will be submitted.

• Brand Name: RESPIRONICS
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 16846104
• MDR Text Key: 314309868
• Report Number: 2518422-2023-10131
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• 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?: No
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/01/2023
• Supplement Dates Manufacturer Received: 05/08/2023
• Supplement Dates FDA Received: 05/11/2023
• 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
• Patient Sex: Male