MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number IN561S

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information alleging during disassembly of the device a burnt humidifier base cable was found.There was no harm or injury reported.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

Event Description

The manufacturer received information alleging during disassembly of the device a burnt humidifier base cable was found.There was no harm or injury reported.In addition to the previous allegation the device is included in the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously received information alleging during disassembly of the device a burnt humidifier base cable was found.There was no harm or injury reported.The b5 describe event or problem description is corrected to include: in addition to the previous allegation the device is included in the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The problem code grid has been updated and h7 and h10 were updated to include recall, and the recall z number.During the initial report an error was made excluding this information, which was found during review.The device has not been returned to the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: REMSTAR AUTO A-FLEX, SYS ONE, 60 SRS
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17825555
• MDR Text Key: 324366759
• Report Number: 2518422-2023-24644
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IN561S
• Device Catalogue Number: IN561S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1