Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS PERFECTO2 V WITH SENSOR 9153650799; GENERATOR, OXYGEN, PORTABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INVACARE FLORIDA OPERATIONS PERFECTO2 V WITH SENSOR 9153650799; GENERATOR, OXYGEN, PORTABLE Back to Search Results
Model Number IRC5PO2V
Device Problems Device Alarm System (1012); Contamination (1120); Leak/Splash (1354); Loose or Intermittent Connection (1371); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Should additional information become available for the patient a supplemental record will be filed.
 
Event Description
Provider states the compressor is loud / sieve contaminated, wire ties used to secure beds, sieve beds blown, muffler contaminated, pilot valve leaks, o-ring causes leaks, power switch has no alarms, wire ties loose and used to repair leaks.
 
Manufacturer Narrative
Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that the compressor was dirty/stained, which confirmed part of the original complaint issue.However, the underlying cause could not be determined.The rest of the parts mentioned in the complaint issue were not returned so their issues could not be confirmed.The following fields were updated accordingly.
 
Event Description
Provider states the compressor is loud / sieve contaminated, wire ties used to secure beds, sieve beds blown, muffler contaminated, pilot valve leaks, o-ring causes leaks, power switch has no alarms, wire ties loose and used to repair leaks.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERFECTO2 V WITH SENSOR 9153650799
Type of Device
GENERATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer (Section G)
INVACARE FLORIDA OPERATIONS
2101 east lake mary blvd
sanford FL 32773
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5322126
MDR Text Key34918643
Report Number1031452-2015-17220
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Replace
Type of Report Initial,Followup
Report Date 01/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIRC5PO2V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received01/13/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-