MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. BIPAPAUTOSVADSYS0NE60SRSDOM; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Fever (1858); Muscle Weakness (1967); Pneumonia (2011); Vomiting (2144); Cancer (3262); Constipation (3274); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/29/2019

Event Type  Injury  

Event Description

My father who is (b)(6), never smoked, never drank, has used asv pap for 4 years and about 9 months.He used a so clean machine and heated humidity daily.He was hospitalized with emesis, weakness and found to have an abcess in his abdomen.He had drains placed.Hospitalized (b)(6) 2019 to (b)(6) 2020 and 19 days tcu discharged home with drains in abdomen.Fell due to weakness again, hospitalized/(b)(6) 2021, one drain removed.Told to flush drain twice daily.On (b)(6) 2021 seen by (b)(6) after biopsy done; on (b)(6) 2021 told results of biopsy, mucinous adenocarcinoma of either appendix or colon.Seen by (b)(6) gastroenterology (b)(6) 2020 assessment: mucinous adenocarcinoma (c80.1), intra-abdominal abscess (k65.1), chronic constipation (k59.09) description: impression: mucinous adenocarcinoma complicated by intra-abdominal abscess.Unclear primary source.Seen by (b)(6) oncology surgeon, didn't recommend surgery, too risky, could be fatal.Cancer is stage 4 due to rupture of abscess.(b)(6) oncologist, didn't recommend chemo, due to poor response for this kind of cancer and would be low quality of life and is slow growing.Gave my father 1-3 year life expectancy.Second opinion at (b)(6), gave my father 3 months to one year.On (b)(6) 2020 3rd hospitalization (father still using so clean and heated humidity.) father woke up throwing up.Fever.Admitted to (b)(6) with pneumonia.Influenza a and b negative.On (b)(6) 2020 presented at tumor conference at (b)(6).At discharge told may be 1 year life expectancy, tumor bigger and now in other area of abdomen.Due to pneumonia, and myself being a pulmonary nurse.An overnight oximetry was done to see if he needed oxygen.The results were very abnormal and oxygen was ordered.Due to the fact it was extremely difficult to pull apart the oxygen adaptor to use the so clean machine, we quit using the so clean machine and just used asv and oxygen since then (washed mask, tubing and humidifier by hand).He used heated humidity set at 2 or 3 out of 5.My father is doing fairly well without abdominal pain or recurrence of emesis.His appetite is good.Due to his need for an advanced asv machine he has continued to use his asv machine since the recall without heated humidity and with a inline filter.He continues to use oxygen with his asv pap machine.Since his initial diagnosis, he has survived a covid hospitalization (b)(6) 2020 and a new diagnosis of congestive heart failure winter of 2021 and has continued to become stronger.Now needing cares 45 minutes daily(down from 4 times daily care) and 2 hours an additional 3 times per week residing in his own apartment condo.We have an order for a new asv machine but it is not currently available(though not technically covered until (b)(6) 2021 as that is when his machine will be 5 years old) at (b)(6).Nor at (b)(6) to my knowledge as they didn't respond to my request.The reason i don't want this submitted with my name or my father's attached to phillips respironics, is because i have worked at a lung and sleep clinic for the last 15 years that dispenses phillips respironics machines.I am afraid for my job if they learn that i have reported this to the fda.They have phone meetings with staff from phillips respironics.My company has been a major distributor, until the recall of only phillips respironics pap machines for (b)(6).They still are distributing machines but only the new nonaffected devices.I have a photo of the serial number, but am having difficulty uploading it; (b)(6) 2020 was date received the diagnosis.Biopsy was a day or two before.Mucinous adenocarcinoma stage 4, complex obstructive sleep apnea, macular degeneration, new diagnosis chf winter 2021.My father has been very healthy his whole life, he was a nonsmoker and didn't drink alcohol.Fda safety report id# (b)(4).

• Brand Name: BIPAPAUTOSVADSYS0NE60SRSDOM
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12377019
• MDR Text Key: 268736713
• Report Number: MW5103515
• Device Sequence Number: 1
• Product Code: MNS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 91 YR
• Patient Weight: 100