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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY USPO2 PULSE OXIMETRY CABLE KIT; OXIMETER

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MASIMO - 52 DISCOVERY USPO2 PULSE OXIMETRY CABLE KIT; OXIMETER Back to Search Results
Model Number 3577
Device Problem Low Readings (2460)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2020
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
 
Event Description
The customer reported the device is providing low readings and the plastic guard has broken off.No patient impact or consequences were reported.
 
Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was evaluated.During visual inspection, the bend relief sleeve was found to be damaged and the latch is missing.The device passed functional testing and the module maintains communication and measurement with cable bending.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit had no product performance issues related to spo2 and pulse rate.The device functions as designed regarding accuracy and measurements.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.
 
Event Description
The customer reported the device is providing low readings and the plastic guard has broken off.No patient impact or consequences were reported.
 
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Brand Name
USPO2 PULSE OXIMETRY CABLE KIT
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11096515
MDR Text Key224533365
Report Number3011353843-2020-00214
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997007481
UDI-Public00843997007481
Combination Product (y/n)N
PMA/PMN Number
K121914
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 12/08/2020
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 Operator Health Professional
Device Model Number3577
Device Catalogue Number3577
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received12/31/2020
Supplement Dates FDA Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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