MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. RESPIRONICS.; VENTILATOR, NON-CONTINUOUS (RESPIRATOR).

Catalog Number DSX500T11C

Device Problem Gas/Air Leak (2946)

Patient Problem Dyspnea (1816)

Event Date 10/14/2021

Event Type  Injury  

Event Description

During the night a strange air flow seemed exploded out blocking my breath and i suddenly woke up.The second time happened after about two months.Then it happened often, and i cannot use this machine anymore.Fda safety report id # (b)(4).

• Brand Name: RESPIRONICS.
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR).
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13798677
• MDR Text Key: 287520397
• Report Number: MW5108221
• 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: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2022
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN CALCIUM 10 MG TAB.; BAUSCH + LOMB PRESERVISION EYE VITAMIN MINERAL SUPPLEMENT AREDS 2 MINI GELS 1 SOFT GEL.; KIRKLAND SIGNATURE ADULT 50 + MATURE MULTI VITAMIN AND MINERALS TAB; NATURE'S BOUNTY CALCIUM 1200 MG 1 SOFTGEL.; NATUREMADE FISH OIL 1200 MG 1 SOFT GEL.; OMEPRAZOLE DR 40 MG CAP.; SPIRONOLACTONE 25 MG TAB.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian