AUTO BI-PAP BIFLEX SYSTEM ONE BIPAP BIFLEX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-19 for AUTO BI-PAP BIFLEX SYSTEM ONE BIPAP BIFLEX manufactured by Respironics.

Event Text Entries

[4925303] Respironics bi-pap auto biflex system one humidification unit failed on 4 different machines. Dme, oxygen plus, walnut creek, ca failed to replace repeated written fax and letter to them and they refused to allow me to returned the machine. I was forced to contact respironics at headquarters writing a letter that had no response. So, i called and they forced oxygen plus to replace non functioning bi-pap 8 months after it failed to function. Sleep specialist dr. (b)(6) at (b)(6), wrong "guessed" on bi-pap low oxygen settings and refused to retest after 90 days as patient, me, reported no improvement. I was getting more ill as diagnosis was severe obstructive sleep apnea. I would stop breathing, wake every 90 minutes with bi-pap and dr. (b)(6) refused to retest. Second opinion by dr. (b)(6), center for sleep disorders informed that the test didn't diagnose and any settings of oxygen pressures were not found to stop the apneas until the test ended. He failed to write his second opinion and failed to perform the test. He stated it needed to be at higher oxygen pressure, which his test was not performed that way. The retesting did prove incorrect first diagnosis. He omitted and wrote incorrect records. Second machine worked only 6 months then stopped working (humidification unit) again they would not replace until i contacted respironics. The third machine never functioned and was returned. Dme refused to provide a cpap since bi-pap wasn't needed. 4th machine broke at six months and i notified dme and they failed to replace. Design problem, if the water receptacle is not placed carefully within the machine, the device will not heat the water. I fall asleep without the mask on because i am waiting for the air to be hot. If not hot, i must replace the water receptacle in the machine several time, until i get hot air. Too many times i have fallen asleep without the mask which is extremely dangerous because i take massive quantities of oxycontin at night. Pain doctor, integrated pain management writes false medical records to protect themselves if i should die at night. They refuse to provide copy or amend the false records. Every time i have received another bi-pap the design has changed. Therefore, they know the machine does not work correctly and they continue to change the design. This causes brain damage, as i stop breathing. (b)(6) is responsible for failing to diagnose my severe obstructive sleep apnea since 2001. Sleep test were not performed until i, the patient , requested the test. The second week of (b)(6) 2010. This medical center has written false medical records and refused to provide a copy and altered my med records. After, i had viewed my med records, after "firing" my pcp for failing to write correct symptoms, and not ordering the sleep test. My med records showed a test was recommend in 2001, 2005, and (b)(6) 2010. My pcp did not order the test. Luckily, my last pcp mentioned the test, so i could scream in the hallway demanding the sleep test. The sleep specialist dr. (b)(6) "guessed" falling to retest. The second opinion sleep specialist informed me of wrong diagnosis by them. He omitted the diagnosis in his report and failed to perform the retesting. He stated he needed to test starting where the previous had ended because no oxygen pressure from 1-17 stopped my apneas. That sleep center did not perform the test that way. They tested the same way, but it proved the first was wrong. Cpap only needed, but no oxygen pressure stopped the apnea; therefore, still no treatment for my severe obstructive sleep apnea. Neither did any of these sleep specialists write a referral to an ear, nose and throat specialist when there was no improvement in my sleep, which is incompetent. The ent informed me too many anatomy problems. Only a tracheotomy tube placement would solve my severe osa but he failed to write a medical record and he failed to refute my confirmation letter he received about the tracheotomy surgery. He failed to remember who i was when i returned for the tracheotomy surgery. He refused to perform it. He would only do piece meal surgeries all failing as he had told me at my original consultation tape recording. (b)(4) board is joke. Letter to postmaster of (b)(6) failing to forward mail going to black hole several times. Another letter to federal postmaster general asking for another post office in another town. (b)(6) sleep center wrote wrong technician on report. Both are bad. (b)(6) center for sleep disorders, failed to perform the repeat testing with the oxygen pressures higher. I was told the test was necessary since first test on (b)(6) 2010 failed oxygen pressures 1-17 did not stop apneas. Therefore, retesting would start at 17 going higher until a pressure stabilized the apnea. I found from (b)(4) that they had filed false claims to medicare as had my first and second sleep specialist, dr. (b)(6). I notified (b)(6) about the false medical records as doctors protect each other from showing any mistakes. My bi-pap machine failed to work when i used in (b)(6) 2011 did not receive another until (b)(6) 2012 retesting proved only cpap not bi-pap was needed. Told never to have children because severe methadone cannot take bad side effects. Live with single older dementia brother, who has financially abuse me don't have money to fix damaged teeth because (b)(6) destroys teeth and my doctors are responsible for failing to treat my illness. My pain management doctor (b)(6) knows medication can kill me he doesn't care.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038322
MDR Report Key4117384
Date Received2014-09-19
Date of Report2014-09-19
Date of Event2010-12-17
Date Added to Maude2014-09-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameAUTO BI-PAP BIFLEX
Generic NameAUTO BI-PAP BIFLEX
Product CodeBYE
Date Received2014-09-19
Model NumberSYSTEM ONE BIPAP BIFLEX
ID NumberSNP08065818MARCH
Device Expiration Date2015-03-18
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0
ManufacturerRESPIRONICS

Device Sequence Number: 2

Brand NameAUTO BI-PAP BIFLEX
Generic NameAUTO BI-PAP BIFLEX
Product CodeBYE
Date Received2014-09-19
OperatorLAY USER/PATIENT
Device Sequence No2
Device Event Key0
ManufacturerRESPIRONICS

Device Sequence Number: 3

Brand NameAUTO BI-PAP BIFLEX
Generic NameAUTO BI-PAP BIFLEX
Product CodeBYE
Date Received2014-09-19
OperatorLAY USER/PATIENT
Device Sequence No3
Device Event Key0
ManufacturerRESPIRONICS

Device Sequence Number: 4

Brand NameAUTO BI-PAP BIFLEX
Generic NameAUTO BI-PAP BIFLEX
Product CodeBYE
Date Received2014-09-19
OperatorLAY USER/PATIENT
Device Sequence No4
Device Event Key0
ManufacturerRESPIRONICS


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2014-09-19

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