MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP A30 VENTILATOR; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	1116151
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2015
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 death, life-threatening in b.2 section, which was marked incorrectly as this is product problem only as mentioned in b.1 section in previous report.G.6 section incorrectly marked 30 days and initial including 15 days, which should marked as 30 days and initial only in this follow up report.G.2 section incorrectly marked in previous report, which is correctly marked as consumer and foreign in this follow up report.
Additional Manufacturer Narrative
In previous report following fields were captured incorrectly, which have been updated/corrected in this report: section b1 and h1 was updated as product problem and malfunction correctly but section b2 was incorrectly selected as death, life threatening and required intervention to prevent permanent impairment/damage, after reveiwing the case it was found that no such serious harm/injury occured to the patient.In section d4 udi number was missed to capture, which was updated.Section e1 was incompletely captured, section g2, 'foreign' was missed to capture, and section g6 it should be initial and 30 days and section h3 have been updated/corrected.

• Brand Name: BIPAP A30 VENTILATOR
• 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: 14132227
• Report Number: 2518422-2022-11350
• Device Sequence Number: 2290960
• Product Code: MNS
• UDI-Device Identifier: 00606959042827
• UDI-Public: 00606959042827
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2023

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: 1116151
• Device Catalogue Number: 1116151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 08/21/2015
• Supplement Date Received by Manufacturer: 08/21/2015; 08/21/2015
• Initial Report FDA Received Date: 04/17/2022
• Supplement Report FDA Received Date: 04/18/2022; 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown