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

Model Number IN561S

Device Problem 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.

• 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: 17782874
• MDR Text Key: 323857756
• Report Number: 2518422-2023-23886
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• 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: 09/07/2023
• 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
• Patient Sequence Number: 1