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

Model Number DS560HS

Device Problems Degraded (1153); Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a philips pap device's sound abatement foam.The user reported the device and/or power cord experienced a thermal event.There was no report of patient harm or injury.There was no serial number, part number, or description of the device provided.Product code bzd has been assigned for trending purposes.Despite multiple attempts by the manufacturer to obtain additional information and request return of the device and its accessories, no further information was provided and no product was returned.The manufacturer concludes no further action is necessary at this time.If additional information is received, or the device is returned and evaluated, a supplemental report will be submitted.

Manufacturer Narrative

The manufacturer received additional information about the device.Hence, sections d1, d4, g4 and h4 updated in this report.

• Brand Name: REMSTAR AUTOA-FLEX
• Type of Device: 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: 15064708
• MDR Text Key: 296219351
• Report Number: 2518422-2022-62892
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005891
• UDI-Public: 00606959005891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS560HS
• Device Catalogue Number: DS560HS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1