MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP S/T C SERIES; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DS1060HS

Device Problem Degraded (1153)

Patient Problem Myocardial Infarction (1969)

Event Date 06/14/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text: device has not yet been returned to the manufacturer for evaluation.

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging having a heart attack.Medical intervention was not specified.The device has not yet been returned to the manufacturer for evaluation.During a good faith effort attempt, the patient stated the device was not able to be returned to the manufacturer.At this time, no further investigation can be performed.If any additional information is received at a later date, an addendum to this final report will be filed.

• Brand Name: BIPAP S/T C SERIES
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 17585017
• MDR Text Key: 321547579
• Report Number: 2518422-2023-20190
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959012554
• UDI-Public: 00606959012554
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DS1060HS
• Device Catalogue Number: DS1060HS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other