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

Model Number	567P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The third-party received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have chronic obstructive pulmonary disease (copd).There is no report of the medical intervention that the patient has received at this time during the evaluation of the device at the third-party service center, the sound abatement foam was found to be degraded.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 previously reported an allegation related to the device's sound abate foam.This action was reported to fda per 21 cf1 part 806.The device will be corrected per res 88058.

• Brand Name: REMSTAR AUTO
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15568
• MDR Report Key: 12213184
• Report Number: 2518422-2021-02383
• Device Sequence Number: 4542396
• Product Code: BZD
• UDI-Device Identifier: 00606959031142
• UDI-Public: 00606959031142
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 567P
• Device Catalogue Number: 567P
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other