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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY PEDI-LITE+; ANALYZER, GAS, CARBON-DIOXIDE, GASEO

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GE HEALTHCARE FINLAND OY PEDI-LITE+; ANALYZER, GAS, CARBON-DIOXIDE, GASEO Back to Search Results
Model Number M1032634
Device Problems Complete Blockage (1094); Obstruction of Flow (2423); Packaging Problem (3007)
Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461); Insufficient Information (4580)
Event Date 06/16/2021
Event Type  Injury  
Manufacturer Narrative
Legal manufacturer: (b)(4).Patient information: this information was not provided by the customer.Model# and device mfr date: the information will be provided in the follow-up report.Ge healthcare's investigation is on-going at this time.A follow-up report will be submitted when the investigation is complete.Device evaluation anticipated, but not yet begun.
 
Event Description
It was reported that a patient undergoing a surgical procedure experienced a cardiopulmonary arrest due to an obstruction caused by a plastic object between the circuit wye and the pedi-lite+ gas monitoring accessory.
 
Manufacturer Narrative
D4: udi is (b)(4).H4: date of manufacture is unknown because the product was not returned to gehc.Investigation findings: gehc requested additional information from the customer however, limited clarification was provided.It was acknowledged that during the event, the gehc anesthesia machine provided multiple alarms to alert the user.The patients current condition is unknown.The plastic object was discarded by the customer but it was alleged that it came from the pedi-lite+ product/packaging.They declined to provide the actual pedi-lite+ involved in the event to gehc engineering for evaluation.Pictures of the affected pedi-lite+ showed an intact device with no indication that the plastic object came from the pedi-lite+ body.Pieces from the same lot as the affected pedi-lite+ were sent gehc engineering whereupon inspection, showed no defects in the product or packaging.In a review of historical data, no other complaints were identified related to this issue.Due diligence when assembling the patient circuit per the instructions for use should allow the issue to be identified prior to connecting the patient.The investigation concluded that based on the data and information available, the root cause was undetermined because the plastic object that was alleged to have caused the obstruction could not be confirmed to have come from the pedi-lite product/packaging.
 
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Brand Name
PEDI-LITE+
Type of Device
ANALYZER, GAS, CARBON-DIOXIDE, GASEO
Manufacturer (Section D)
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki FIN-0 0510
FI  FIN-00510
Manufacturer (Section G)
GE HEALTHCARE FINLAND OY
kuortaneenkatu 2
helsinki FIN-0 0510
FI   FIN-00510
Manufacturer Contact
kristof soos
8200 w tower ave
milwaukee, WI 53223
MDR Report Key12339731
MDR Text Key267211590
Report Number9610105-2021-00004
Device Sequence Number1
Product Code CCK
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K183394
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberM1032634
Device Lot Number008128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/23/2021
Initial Date FDA Received08/18/2021
Supplement Dates Manufacturer Received11/18/2021
Supplement Dates FDA Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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