MAUDE Adverse Event Report: RESPIRONICS, INC. L, AF541 EE LK 1, CAPSTRAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Leak/Splash (1354)

Patient Problems Convulsion/Seizure (4406); Unspecified Heart Problem (4454)

Event Date 03/18/2024

Event Type  Injury  

Event Description

The manufacturer became aware of an allegation of af541 capstrap that the patient alleges during clinical and therapeutic use, it was noted that the access/entrainment port on the non-invasive interface was opened, resulting in an unanticipated leak in the system.The patient suffered a desaturation of peripheral oxygenation (unspecified), increased heart rate (unspecified), and multiple seizures.The port on the interface was closed and therapy settings titrated with recovery of the patient noted.The patient is still currently utilizing the device.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.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.

• Brand Name: L, AF541 EE LK 1, CAPSTRAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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: 19047642
• MDR Text Key: 339435298
• Report Number: 2518422-2024-16358
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female