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

Model Number 989803204531

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported that the microstream co2 adaptor & smiths et tube stuck together resulting in not being able to suction critically ill patients.

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 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.

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), timna consumables risk management file).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.

Event 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.

• Brand Name: MICROSTREAM¿¢ ADVANCE NEONATAL-INFANT INTUBATED CO2 FILTER LINE
• Type of Device: 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: 17625374
• MDR Text Key: 321977982
• Report Number: 1218950-2023-00607
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 20884838093137
• UDI-Public: 20884838093137
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989803204531
• Device Catalogue Number: 989803204531
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other