MAUDE Adverse Event Report: RESPIRONICS INC DREAMSTATION AUTO CPAP, W/HUMID/HT, KR; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	KRX500T15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A continuous positive airway pressure (cpap) device was returned to the manufacturer for service.The device was not in patient use.During the evaluation of the device at the manufacturer's service center, an issue related to the device's sound abatement foam was observed.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

• Brand Name: DREAMSTATION AUTO CPAP, W/HUMID/HT, KR
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 12453612
• Report Number: 2518422-2021-03811
• Device Sequence Number: 19850351
• Product Code: BZD
• UDI-Device Identifier: 00606959043381
• UDI-Public: 00606959043381
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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: KRX500T15
• Device Catalogue Number: KRX500T15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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