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: PRECISION MEDICAL, INC PM5200 SERIES,BLENDER,AIR/O2,HIGH FLOW; MIXER, BREATHING GASES, ANESTHESIA INHALATION
  • 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
 

PRECISION MEDICAL, INC PM5200 SERIES,BLENDER,AIR/O2,HIGH FLOW; MIXER, BREATHING GASES, ANESTHESIA INHALATION Back to Search Results
Model Number PM5200
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/27/2022
Event Type  malfunction  
Event Description
Nicu pod bedspace.Multiple attempts at changing this patient to bubble cpap (continuous positive airway pressure) from niv nava (noninvasive neurally adjusted ventilatory assist) have failed over the past several weeks.An equipment malfunction was found this evening with the oxygen blender.Flow was being given; however, unknown what the fio2 (fraction of inspired oxygen) was.According to the malfunctioning blender, we were having to administer 80% and patient would subsequently have to be placed back to niv nava.This has occurred multiple times with this patient.The blender in question was replaced this evening and the issue was resolved.There appeared to be no detrimental or harmful effects to the patient.Issue resolved on date redacted 2000hrs.
 
Event Description
Nicu pod bedspace.Multiple attempts at changing this patient to bubble cpap (continuous positive airway pressure) from niv nava (noninvasive neurally adjusted ventilatory assist) have failed over the past several weeks.An equipment malfunction was found this evening with the oxygen blender.Flow was being given; however, unknown what the fio2 (fraction of inspired oxygen) was.According to the malfunctioning blender, we were having to administer 80% and patient would subsequently have to be placed back to niv nava.This has occurred multiple times with this patient.The blender in question was replaced this evening and the issue was resolved.There appeared to be no detrimental or harmful effects to the patient.Issue resolved on [date redacted] 2000hrs.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PM5200 SERIES,BLENDER,AIR/O2,HIGH FLOW
Type of Device
MIXER, BREATHING GASES, ANESTHESIA INHALATION
Manufacturer (Section D)
PRECISION MEDICAL, INC
300 held dr
northampton PA 18067
MDR Report Key14799515
MDR Text Key294676589
Report Number14799515
Device Sequence Number1
Product Code BZR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 06/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberPM5200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/09/2022
Date Report to Manufacturer06/24/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/24/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/24/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-