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

Model Number	560PBT
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Headache (1880); Sore Throat (2396); Respiratory Tract Infection (2420); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Event or Problem 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 visualization of particles.There was no report of serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer received new and relevant information on 03/02/2023 alleging aluminium headache, nasal/throat irritation related to a cpap device's sound abatement foam.Clinical codes are added to the h6 section.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to sound abatement foam.Corrected information was provided in h6, b7 and section h10 should be reported as: 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 previously received information alleging visualization of particles, headaches and nasal/throat irritation or soreness related to a cpap device's sound abatement foam.There was no report of patient harm or injury.After the third attempt to have the device and components returned for evaluation, the customer stated that the device was not available to be returned, customer did not receive replacement and currently using the recalled device.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Corrected information was provided in b7, the information (patients underlying health condition includes mental disorders like post-traumatic stress disorder (ptsd)) was not reported in earlier report.Section h6 health effect- impact code (soreness), type of investigation findings and investigation conclusions has been updated.

• Brand Name: REMSTAR AUTO
• Common Device Name: 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 15206 ; 2673970028
• MDR Report Key: 15486954
• Report Number: 2518422-2022-83167
• Device Sequence Number: 7831589
• Product Code: BZD
• UDI-Device Identifier: 00606959042858
• UDI-Public: 00606959042858
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 560PBT
• Device Catalogue Number: 560PBT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 03/02/2023; 03/02/2023
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 03/03/2023; 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown