MAUDE Adverse Event Report: RESPIRONICS, INC. A30 SILVER SERIES; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1116151
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The device was returned and the manufacturer has confirmed of defective blower and bottom enclosure.
Additional Manufacturer Narrative
The manufacturer previously reported incorrect data in section b2, which was rectified in previous follow-up.Section b5,d8, d9, e1,h3 was incorrectly reported in the previous report, which correctly updated in this follow up report.Section g2 was marked incorrectly in previous report as consumer and company representative.The report should have been sent for foreign and consumer in g2.Section g6 was marked incorrectly in previous report as 15days.The report should have been sent for 30 days and initial in g6.

• Brand Name: A30 SILVER SERIES
• 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: 15200250
• Report Number: 2518422-2022-11389
• Device Sequence Number: 17745716
• Product Code: BZD
• UDI-Device Identifier: 00606959042827
• UDI-Public: 00606959042827
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 1116151
• Device Catalogue Number: 1116151
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2016
• Supplement Date Received by Manufacturer: 05/23/2016
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2015
• 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