MAUDE Adverse Event Report: RESPIRONICS, INC. WISP NASAL MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Product Quality Problem (1506)

Patient Problems Convulsion/Seizure (4406); Unspecified Nervous System Problem (4426); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer became aware that a user of the wisp nasal mask alleges seizure, hospitalization, continuing and long lasting physical, neurological, psychological, and emotional injuries & damages.The patient also alleges failure to warn, design defect, manufacturing defect, negligence, breach of express and implied warranties and loss of consortium.The device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: WISP NASAL MASK
• 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: 18064849
• MDR Text Key: 327275391
• Report Number: 2518422-2023-28709
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• 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
• Date Manufacturer Received: 10/05/2023
• 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): Hospitalization