MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	BLX500H15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused neuro endocrine cancer tumors.The patient did receive medical intervention in the form of surgery.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported mdr 2518422-2021-04240 as the investigation is ongoing and a follow up report will be submitted when the manufacturer has completed the investigation.The correct text should state the following.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.Correction to h7: recall.Correction to h9: res 88058.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to a cpap device's sound abatement foam and became degraded and caused neuro endocrine cancer tumors.The patient did receive medical intervention in the form of surgery.Section g3 was corrected to reflect the bad when new information was received.
Additional Manufacturer Narrative
The manufacturer previously reported an allegation of an issue related to a cpap device's sound abatement foam and became degraded and caused neuro endocrine cancer tumors.The patient did receive medical intervention in the form of surgery.Despite multiple attempts on (b)(6) 2021, (b)(6) 2022, (b)(6) 2022, the device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Section h6 updated in this report.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 12510278
• Report Number: 2518422-2021-04240
• Device Sequence Number: 5173758
• Product Code: BZD
• UDI-Device Identifier: 00606959027350
• UDI-Public: 00606959027350
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BLX500H15
• Device Catalogue Number: BLX500H15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 09/22/2021; 04/06/2022
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 09/22/2021; 08/09/2022; 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2017
• 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: Other
• Patient Sex: Male