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

Model Number REF: 1091398

Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

There was a recall notice on my philips respironics remstar auto a-flex system one.The problem is the serial number has been erased by usage (placed a wrong position under the machine) and when i called the recall number, they refused to help till i provide a serial no.So i am in a limbo, this was given to me by (b)(6) through (b)(6) in approximately 2016, who are not able to provide the serial no to me.How do i get this resolved with philips? fda safety report id #(b)(4).

• Brand Name: PHILIPS RESPIRONICS REMSTAR AUTO A-FLEX SYSTEM ONE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 15233760
• MDR Text Key: 298084502
• Report Number: MW5111490
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: REF: 1091398
• Device Catalogue Number: N/A SEE PHOTO
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE 50 MCG TABLET,ATORVASTATIN 20 MG TAB MYLA,GLIPIZIDE ER 2.5 MG TABLET; MULTI VITAMIN, FISH OIL
• Patient Outcome(s): Life Threatening
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander