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

Model Number 1119080

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Tissue Breakdown (2681)

Event Date 08/27/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer became aware of an allegation that an end user developed a bedsore while using an amara gel mask.The patient's attending physician states the patient has been using the amara gel mask since (b)(6) 2023.The attending physician alleges "the mask had contact with the patient's nose and a bedsore developed on the nasal bone part and on portions which had contact with the mask".The patients attending doctor also alleges that it is "highly possible that there is causality between the mask and patient harm, it is hard to imagine any other causes, and the symptom can be improved by stopping using the mask or changing the mask to one which does not have contact with the nasal bone part".The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow up report will be filed.

• Brand Name: AMARA GEL 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: 18269137
• MDR Text Key: 329748372
• Report Number: 2518422-2023-33622
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1119080
• Device Catalogue Number: 1119080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• 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): Other
• Patient Age: 85 YR
• Patient Sex: Female