MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTO A-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 560P

Device Problem Degraded (1153)

Patient Problems Dry Eye(s) (1814); Headache (1880); Itching Sensation (1943)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

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 patient alleges headache, earaches, sinus infection, dry eyes and itching.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

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 patient alleges headache, earaches, sinus infection, dry eyes and itching.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.After further review, this report is now being filed as an adverse event instead of a product problem.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

On previously submitted report, section "adverse event/product problem" in box b was incorrect.In this report, section "adverse event/product problem" in box b has been updated/corrected.

Manufacturer Narrative

The manufacturer previously reported 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 patient alleges headache, earaches, sinus infection, dry eyes and itching.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.After further review, this report is now being filed as an adverse event instead of a product problem.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.On previously submitted report, section "adverse event/product problem" in box b was incorrect.In this report, section "adverse event/product problem" in box b has been updated/corrected.The report had been filed correctly as an adverse event and boxes b and h have been updated to reflect the correction from the previous submission.

• Brand Name: REMSTAR AUTO A-FLEX
• 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: 17515099
• MDR Text Key: 320929643
• Report Number: 2518422-2023-19499
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030497
• UDI-Public: 00606959030497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• 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,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 560P
• Device Catalogue Number: 560P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2012
• 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