MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MICROSTREAM¿¢ ADVANCE NEONATAL-INFANT INTUBATED CO2 FILTER LINE

Model Number	989803204531
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the microstream co2 adaptor & smiths et tube stuck together resulting in not being able to suction critically ill patients.
Additional Manufacturer Narrative
Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.
Event or Problem Description
The customer stated that the patient required an additional medical procedure (outside the scope of normal treatment).The reported potential harm is classified as serious.
Additional Manufacturer Narrative
The type of complaint has been updated from product problem to serious injury.Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.
Event or Problem Description
Philips received a complaint on the neonatal-infant intubated co2 filter line, extended duration indicating a potential neonatal patient safety issue due to microstream co2 adaptor & smiths et tube sticking together resulting in not being able to suction a critically ill patient.Some instances resulted in a patient having to be extubated so that they can be suctioned and the airway having to be reinserted.
Additional Manufacturer Narrative
Several good faith efforts (gfe) were made to obtain additional information associated with this complaint, but attempts have been unsuccessful.Based on the information available and the cause of the reported problem was unknown.The pms clinical expert reviewed the reported event of the microstream co2 adaptor sticking to the smiths et tube.This resulted in the inability to suction critically ill patients, which resulted in the inability to maintain the patient's airway, a life-threatening condition for the patient.Emergency intervention, including extubation and reintubation, was performed to preclude permanent impairment.This event is assessed as possibly related to a product problem with the device.However, the event does not appear to be predicted in the risk management document ((b)(4)).This holder of this document is medtronic.The event is no longer meets criteria for reporting by philips as the product that caused or contributed to the event was a non-philips product.

• Brand Name: MICROSTREAM¿¢ ADVANCE NEONATAL-INFANT INTUBATED CO2 FILTER LINE
• Common Device Name: MICROSTREAM¿¢ ADVANCE NEONATAL-INFANT INTUBATED CO2 FILTER LINE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17624431
• Report Number: 1218950-2023-00605
• Device Sequence Number: 12296134
• Product Code: CCK
• UDI-Device Identifier: 20884838093137
• UDI-Public: 20884838093137
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 989803204531
• Device Catalogue Number: 989803204531
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 08/03/2023; 01/24/2024
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 11/01/2023; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown