MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS; AIRWAY ADAPTER

Model Number M2533A

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Low Oxygen Saturation (2477)

Event Date 08/03/2018

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.The customer wanted to manually ventilate the patient, but the ventilator tubing was extremely stiff and they were unable to disconnect it.They tried again and the end of the et tube (blue part) dislodged from et tube.The patient became unresponsive and saturations were dropping.The customer reported that the crash bell was pulled immediately, cpr was started and a pulse was obtained.The patient was manually ventilated and suctioned and oxygen saturations improved.The customer reported that the end of the et tube was changed by the icu registrar and the patient was placed back on a ventilator.

Event Description

The customer claimed that they had an incident on (b)(6) 2018 involving a pediatric patient.The customer claimed that, at approximately 23:00 post cares, the patient was desaturating.It was reported that the patient arrested and required cpr.

Manufacturer Narrative

However, (b)(6) (head of itu support, biomedical engineering) advised philips that the device was not retained.Therefore, evaluation of the device involved in the incident could not be performed.Additional information regarding the reported incident was requested.(b)(6) provided some additional information, but she indicated that it is unlikely that she could obtain all of the requested information and stated that she would ask that the information philips requested be recorded for any future incidents.The additional information that (b)(6) provided was that the adaptor would have been the adult one as the ventilator was an evita xl with flow sensor and the infant connector does not fit on to the flow sensor.The customer also stated that the patient was on an un-cuffed 3.5mm et tube, part number 100/111/035.According to the philips senior product manager, this set-up is not ideal from clinical set-up standpoint as there would be a large amount of dead space.Dead space in a breathing circuit is the space where inhalation and exhalation coincide, but the amount of dead space in a breathing circuit would not likely have caused or contributed to this reported issue.Since very little information about the reported issue was available from the customer and there was no immediate indication that the philips device had malfunctioned, other possible causes were discussed.According to the philips senior product manager, it is possible for the user to ¿jam¿ (overexert) the different pieces of the airway circuit together with their own two hands and that there is a difference between the airway circuit pieces fitting snug and being forced together.To try to understand the customer¿s method of connecting the airway circuit and to understand the cause of the reported issue, philips sent additional questions to the customer.The customer did not provide answers to any of the additional questions.As a result, we are considering the cause of this reported issue to be unknown.The customer reported that the patient was manually ventilated and suctioned and oxygen saturations improved.The customer reported that the icu registrar changed the end of the et tube and the patient was placed back on a ventilator.Philips performed a mechanical investigation to ensure that all connectors meet all specifications and that measurement of philips¿ device compared to specification showed the device to be print compliant.The location of the device involved in this incident is unknown.The investigator is closing this complaint under good faith effort made, but the complaint can be reopened upon receipt of additional information.

• Brand Name: PHILIPS
• Type of Device: AIRWAY ADAPTER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7866099
• MDR Text Key: 119923720
• Report Number: 1218950-2018-07184
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

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
• Device Operator: Health Professional
• Device Model Number: M2533A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 08/22/2018
• Supplement Dates FDA Received: 11/20/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention