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

Model Number 560P

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Anemia (1706); Nerve Damage (1979); Weight Changes (2607); Cancer (3262)

Event Date 01/05/2021

Event Type  Injury  

Event Description

Left lower lobe lung lobectomy for 2 cm cancerous tumor complaint: left thoracic nerve injury with abdominal bulge-permanent.Chemotherapy: (b)(6) 2021 - cisplatin and alimta.Followed by tagrisso (target medication) for three (3) years.Permanent anemia.Left abdominal wall distortion-permanent; 20 lb weight loss.Use cpap machine nightly without fail 8-10 hours, 365 days/year.

• Brand Name: PHILIPS RESPIRONICS REMSTAR AUTO A-FLEX
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15028332
• MDR Text Key: 296066396
• Report Number: MW5110886
• 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: Physician
• Type of Report: Initial
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 560P
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABILIFY; ASA 81MG; CYMBALTA ; DEXILANT; FLOMAX ; FOLIC ACID; JANUVIA ACTOS +MET; LIPITOR; LOSARTAN ; PROBIOTIC ; SELENIUM; TAGRISSO; TOPROL ; VIT D3; WELLBUTRIN ; ZETIA
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White