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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-8, HORIZONTAL; OXIMETER
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MASIMO - 40 PARKER RAD-8, HORIZONTAL; OXIMETER Back to Search Results
Model Number 22042
Device Problem Failure To Run On AC/DC (1001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
The device has been returned to the local facility but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.
 
Event Description
The customer reported the device switches off by itself.No patient impact or consequences were reported.
 
Manufacturer Narrative
The returned device was evaluated.During evaluation, the device was able to power on using both ac and dc power.When powered on the device was able to obtain readings and alarmed audibly and visually under alarm conditions.The device was charged overnight, the unit remained on for approximately one hour prior to sounding a low battery alarm and shutting down.Internal inspection showed the top shell has cosmetic damage on the inside and that the battery voltage measured 6.2 vdc.The device did not turn off by itself during testing however the battery does not hold an adequate charge.A service history record review reveals that this unit was in the field for over seven (7) years with no previous reported issues related to this reported event.
 
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Brand Name
RAD-8, HORIZONTAL
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key7287997
MDR Text Key100777967
Report Number2031172-2018-00107
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 distributor,foreign,health pr
Remedial Action Other
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number22042
Device Catalogue Number9190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2018
Was the Report Sent to FDA? Yes
Date Manufacturer Received02/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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