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: MASIMO - 15750 ALTON PKWY RADICAL-7 HANDHELD; OXIMETER
  • 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
 

MASIMO - 15750 ALTON PKWY RADICAL-7 HANDHELD; OXIMETER Back to Search Results
Model Number 25052
Device Problem Device Alarm System (1012)
Patient Problem Cyanosis (1798)
Event Date 10/17/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the investigation facility to allow for an analysis to be performed.If the product is received for evaluation or new information is obtained, a follow up report will be submitted.
 
Event Description
The customer reported the device was being used for monitoring saturation and heart rate for approximately 19 hours prior to event.Patient was found cyanotic, pale, unresponsive, and no alarm was observed.
 
Event Description
The customer reported the device was being used for monitoring saturation and heart rate for approximately 19 hours prior to event.Patient was found cyanotic, pale, unresponsive, and no alarm was observed.
 
Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.No external damage or defects were observed.The unit did not power on using battery power but was able to power on and off using ac power.The battery would not charge and the unit would shut off once undocked.All alarm conditions were audible and visual and the trend data indicates that the unit alarmed both audibly and visually due to low spo2 and pr on the day of the event.The battery diagnostics indicate a battery voltage of 2784mv (failed) and a full charge capacity of 3833mah (acceptable).The device was placed in a burn-in oven for 4 hours at 35c and no errors occurred and the alarm remained audible.Internal inspection found no physical defect or damages and there was acceptable impedance was measured across the speaker.Customer's complaint was not duplicated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RADICAL-7 HANDHELD
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 15750 ALTON PKWY
15750 alton pkwy
irvine CA 92618
Manufacturer (Section G)
MASIMO - MEXICALI
industrial vallera de mexicali calzada del oro, no.2001
mexicali, baja california 21600
MX   21600
Manufacturer Contact
matofa fautua
15750 alton pkwy
irvine, CA 92618
9498223661
MDR Report Key12965016
MDR Text Key281978390
Report Number3019388613-2021-00340
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K110028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25052
Device Catalogue Number9500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-