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 - 40 PARKER RAD-8, HORIZONTAL; 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 - 40 PARKER RAD-8, HORIZONTAL; OXIMETER Back to Search Results
Model Number 22042
Device Problems Failure To Run On AC/DC (1001); No Audible Alarm (1019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/06/2018
Event Type  malfunction  
Manufacturer Narrative
Multiple attempts for product return and requests for additional information were made.The product has not been returned to masimo to allow an analysis to be performed.If new information is obtained or the product is returned, a follow up report will be submitted.
 
Event Description
The customer reported the low priority alarm did not actuate when the device was in a low battery condition.The device could only run on internal battery for less than one hour and was unable to provide an audible alarm before shutting down.No patient impact or consequences were reported.
 
Event Description
The customer reported the low priority alarm did not actuate when the device was in a low battery condition.The device could only run on internal battery for less than one hour and was unable to provide an audible alarm before shutting down.No consequences or impact to patient was reported.
 
Manufacturer Narrative
The returned device was evaluated.During analysis the unit was unable to power on until the device was connected to ac power.The unit was able to engage in monitoring activities but shut down when disconnected from ac power.The failure was isolated to the unit's battery.A new battery was installed and the unit functioned as designed.No anomalies were found in internal inspection.A service history record review reveals that this unit was in the field for over three (3) year with no previous reported issues related to this reported event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RAD-8, HORIZONTAL
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key7387479
MDR Text Key104182818
Report Number2031172-2018-00179
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
PMA/PMN Number
K092838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number22042
Device Catalogue Number9190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2018
Was the Report Sent to FDA? No
Date Manufacturer Received07/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-