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

Model Number DS560S

Device Problems Degraded (1153); No Apparent Adverse Event (3189)

Patient Problems Convulsion/Seizure (4406); Epilepsy (4407); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged visualization of particles.There is no allegation of serious or permanent harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported in section b.2.Required intervention to prevent permanent impairment/damage.After review, it was determined no required intervention to prevent permanent impairment/damage was reported and this was incorrectly marked in section b.2.The report should have been sent for product problem only in section b.1.

Manufacturer Narrative

The manufacturer previously received information alleging visualization of particles related to a cpap device's sound abatement foam.There was no report of patient harm or injury.The manufacturer received new and relevant information on (b)(6) 2022 patient alleging seizure, epilepsy related to a cpap device's sound abatement foam.In addition, appropriate health effect - clinical code has been added on h6 section.Section b1, b3, g3, h1, h2, h3 and h6 updated/corrected.

Manufacturer Narrative

The manufacturer was previously 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 a continuous positive airway pressure (cpap) device's sound abatement foam became degraded and caused the patient seizure, epilepsy.The patient also alleged visualization of particles.Despite of multiple attempts the device has not yet returned to the manufacturer for evaluation.There has been no response from the customer on the return of the device.At this time, no further investigation can be performed.If any additional information is received, a follow-up report will be filed.

• Brand Name: REMSTAR AUTO A-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: 14597483
• MDR Text Key: 293446846
• Report Number: 2518422-2022-29470
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005884
• UDI-Public: 00606959005884
• 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,Followup,Followup
• Report Date: 01/04/2023

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: DS560S
• Device Catalogue Number: DS560S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 05/12/2022; 10/26/2022; 10/26/2022
• Supplement Dates FDA Received: 07/08/2022; 12/27/2022; 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention