MAUDE Adverse Event Report: PHILIPS-RESPIRONICS EVERFLO; GENERATOR, OXYGEN, PORTABLE

Catalog Number 1020001

Device Problems Delayed Alarm (1011); No Audible Alarm (1019)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Event Description

Spoke w/ pt's daughter in law and she stated that the back up had shown a yellow indicator light but no alarm, she did not know how much time had passed since the moment the yellow light had come on, she had shut it off again and the yellow light came on again w/ no alarm within 5-10 minutes.Did confirm that the patient uses a humidifier bottle and the daughter in law changes them regularly.Had troubleshot w/ the daughter in law and so far the backup had not given a yellow light.Did let her know what may happen with kinked tubing and humidifier bottles but the concerning issue was that the alarm did not sound when the indicator light came on.Also, confirmed that the patient has the backup attached directly to the wall outlet.Pt was sent to the hospital last night after they checked his stats and found that he was in his low 70's and then placed him on the lnogen portable which was a bit difficult to bring him back to his normal sats.Without success to raise is 02 levels they took him to the hospital.Sn-(b)(6) pn: 1020001 sending a replacement backup for overnight delivery.Daughter in law will call with updates.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: EVERFLO
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): PHILIPS-RESPIRONICS
• MDR Report Key: 17516596
• MDR Text Key: 321049279
• Report Number: MW5123545
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 1020001
• Patient Sequence Number: 1
• Patient Age: 82 YR