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

Model Number CA461NTS

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Headache (1880); Dizziness (2194); Chronic Obstructive Pulmonary Disease (COPD) (2237); Sore Throat (2396); Eye Burn (2523); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient to have cardiovascular diagnosis.The patient did receive medical intervention in the form of stent placement in heart.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.  additional information was received and section b5 should be 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 bipap device's sound abatement foam.The patient alleged to to havebecame degraded and caused the patient to have cardiovascular diagnosis.There was no medical intervention required by the patient.The reported event of to became degraded and caused the patient to have cardiovascular diagnosis was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.  the device has not yet returned to the manufacturer for evaluation.The patient has swapped out the deice at the distributor and at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.  section(s) b1, b2,  has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.A correction to b5 was made and should be: 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 previously received information alleging the patient eye burning, heart stents, cardiovascular diagnosis, emphysema, copd, service message displayed, headaches, chronic dizziness, lightheaded, device gets warm, bed side table warped, chronic dry throat, irritated sinuses and odor related to a cpap device's sound abatement foam.The medical intervention that the patient received in response to the event is currently unknown.The device was returned to the manufacturer's quality product investigation laboratory for investigation.Observed the following from internal and external inspection -an unknown dust contaminant on the pca and water tank lid, blower cap, side panel, blower, bellow, inlet seal, and bottom enclosure.Evidence of sound abatement foam degradation/breakdown was not observed.The tank lid was also observed to have the clip broken where it clips to the tank.Evidence of liquid ingress with mineral deposits was observed to the water tank.An unknown dark contaminant, possibly a mildew bacterium, was observed on the flip lid seal.An unknown dust contaminant was observed on the dry box inlet seal and the dry box seal.An unknown contaminant and dust contaminant were observed on the bottom enclosure.The bottom enclosure screws were observed to be corroded, consistent with liquid ingress to them.An unknown dust contaminant was observed to the lower base.The device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer.There was one instance of e-53 (err_comp_log_sem_timeout)error found.The manufacturer concludes,that they could not confirm the customer complaint and they confirmed there is no presence of degraded sound abatement foam.Section h6 was missed to capture in previous mdr ,now it is corrected and updated in this report.

• Brand Name: REMSTAR PRO C-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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 2673970028
• MDR Report Key: 13064296
• MDR Text Key: 282704844
• Report Number: 2518422-2021-08558
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030152
• UDI-Public: 00606959030152
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2023

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: CA461NTS
• Device Catalogue Number: CA461NTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 05/04/2023; 11/14/2023
• Supplement Dates FDA Received: 04/18/2023; 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• 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