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

Model Number	IN561HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to suffer injuries.The medical intervention that the patient received in response to the event is currently unknown.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 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 an issue related to the device's sound abatement foam became degraded and caused the patient to have pain and suffer injuries.The medical intervention that the patient received in response to the event is currently unknown.Despite multiple attempts on (b)(6) /2022, (b)(6) 2022, (b)(6) 2022, the device has not yet 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.Section h6 updated in this report.

• Brand Name: REMSTAR AUTOA-FLEX
• 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: 14647377
• Report Number: 2518422-2022-34292
• Device Sequence Number: 12156309
• Product Code: BZD
• UDI-Device Identifier: 00606959030763
• UDI-Public: 00606959030763
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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: IN561HS
• Device Catalogue Number: IN561HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown