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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER USPO2 PULSE OXIMETRY CABLE KIT; OXIMETER

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MASIMO - 40 PARKER USPO2 PULSE OXIMETRY CABLE KIT; OXIMETER Back to Search Results
Model Number 3577
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/27/2018
Event Type  malfunction  
Manufacturer Narrative
Additional manufacturing narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
 
Event Description
The customer reported cables are breaking fairly often and they stopped working.No patient impact or consequences were reported.
 
Manufacturer Narrative
The returned device was evaluated.External visual inspection showed a cut along the length of the outer jacket of the cable.During evaluation, the device passed all functional testing.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.
 
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Brand Name
USPO2 PULSE OXIMETRY CABLE KIT
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.
calzada del oro, no. 2001
parque industrial palaco
mexicali, baja california 21600
MX   21600
Manufacturer Contact
erica kline
52 discovery
irvine, CA 92618-1604
9492977000
MDR Report Key7453247
MDR Text Key106260538
Report Number2031172-2018-00243
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997007481
UDI-Public00843997007481
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121914
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
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 Manufacturer05/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 03/27/2018
Initial Date FDA Received04/23/2018
Supplement Dates Manufacturer Received06/02/2018
Supplement Dates FDA Received06/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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