MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP S/T C SERIES INTL 30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1061T
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A ventilator was returned for service.There was no harm or injury reported.During the evaluation at the manufacturer's service center, the sound abatement foam was replaced for repair.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.
Additional Manufacturer Narrative
The manufacturer previously reported in outcomes attributed to adverse event hospitalization (initial or prolonged) & required intervention to prevent permanent impairment/damage.After review, it was determined no required intervention to prevent permanent impairment/damage & hospitalization (initial or prolonged) was reported and this was incorrectly marked in outcomes attributed to adverse event.In brand name previously it was submitted dreamstation bipap st.But the correct brand name is bipap s/t c series intl 30.In initial reporter name and address previously it was submitted (b)(6).Initial reporter name and address is updated to (b)(6).Report source was marked incorrectly in previous report as consumer and company representative.The correct report source should be marked consumer and foreign in report source.Type of report marked as 15 day.But the correct report is 15 day should not be present.In device evaluated by mfr previously it was marked with yes.But the correct mark should be no.

• Brand Name: BIPAP S/T C SERIES INTL 30
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• 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: 13777079
• Report Number: 2518422-2022-09502
• Device Sequence Number: 19284060
• Product Code: MNS
• UDI-Device Identifier: 00606959039186
• UDI-Public: 00606959039186
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: 1061T
• Device Catalogue Number: 1061T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2015
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown