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

Model Number 561P

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Fever (1858); Headache (1880); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/13/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused a patient to develop asthma.The patient was prescribed medication in response to the reported event.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Section b5 should be previously reported as: the manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.Patient was alleging to develop asthma, headaches, air bloating stomach, cough up mucus, got impaired lung, cold and fever.Patient was prescribed medication in response to the reported event.Since there is no customer information, the manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this a follow-up report will be filed.Section g1 updated.Section g4 corrected.Section h6 health effect - clinical codes which was missed in previous report was captured.Section h6 type of investigation findings and investigation conclusions has been updated.

• Brand Name: REMSTAR AUTO, INTL
• 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: 12448956
• MDR Text Key: 270631387
• Report Number: 2518422-2021-03859
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030572
• UDI-Public: 00606959030572
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 561P
• Device Catalogue Number: 561P
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2013
• 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
• Patient Outcome(s): Other