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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS / RESPIRONICS INC. PHILIPS REMSTAR AUTO A-FLEX CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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PHILIPS / RESPIRONICS INC. PHILIPS REMSTAR AUTO A-FLEX CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Device Problems Nonstandard Device (1420); Patient Device Interaction Problem (4001)
Patient Problems Arthritis (1723); Dyspnea (1816); Pain (1994); Blurred Vision (2137); Visual Impairment (2138); Skin Inflammation/ Irritation (4545)
Event Date 06/25/2021
Event Type  Injury  
Event Description
Patient called to report adverse symptoms he believes is related to his recalled philips cpap machine.Patient stated that he has been experiencing symptoms including: breathing problems, nasal passage irritation, vision impairment, blurred vision, congestion, severe foot pain in right foot which turned out to be gout, increase in arthritis symptoms including shoulder, thumb and wrist area, more than normal discharge in nasal passage, and eye irritation.Patient stated that he's discovered if he sleeps on his left side and at a 30 degree angle without the cpap, his symptoms are lessened.Patient stated he learned about the recall by mailed letter which he believes he received in early july.
 
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Brand Name
PHILIPS REMSTAR AUTO A-FLEX CPAP
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
PHILIPS / RESPIRONICS INC.
MDR Report Key12392320
MDR Text Key269420390
Report NumberMW5103612
Device Sequence Number1
Product Code BZD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/30/2021
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 No Information
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/30/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age82 YR
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