MAUDE Adverse Event Report: HAMILTON MEDICAL AG BREATHING CIRCUIT SET, DUAL LIMB; BREATHING CIRCUIT SET, DUAL LIMB FOR C1/T1/T1 MILITARY/MR1

Model Number	260170
Medical Device Problem Codes	Fitting Problem (2183); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).Investigation still ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: this event was reported to hamilton as the breathing circuit set could not be connected to the cpap mask (for children).This occurrence was noticed when the patient needed to be connected for ventilation.As a result of struggling to connect the breathing mask to the breathing circuit, some ventilator alarms were activated.The device log files were not provided to hamilton.There is patient involvement reported (infant, 20 months old, 9kg).There was need for medical intervention reported.The ventilator device and the breathing circuit set got replaced.Neither harm to the patient, user or third party has been reported.There is no delay in treatment reported as such but based on the information what has been reported, it can be concluded that this event caused a certain degree of uncertainty between the hospital staff.The investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is cer (b)(4).Investigation stil ongoing.A detailed investigation was performed by an expert from the technical service: with this investigation it has been confirmed that the device worked as intended at the time of the event.The affected breathing circuit set (neonatal) could not be connected to the cpap mask (for children) due to a different diameter of the mask.This occurrence was noticed when the patient needed to be connected for ventilation during transportation.As a result of struggling to connect the breathing mask to the breathing circuit, there were operational uncertainties.There is patient involvement reported (infant, 20 months old, 9kg).There was need for medical intervention reported as the ventilator device and the breathing circuit set got replaced.Neither harm to the patient, user or third party has been reported.There is no delay in treatment reported as such but based on the information what has been reported, it can be concluded that this event caused a certain degree of uncertainty between the hospital staff.The issue is not likely to be serious to public health but has potential to cause a delay in treatment or an intervention (replacement of the ventilator), if it were to recur during the use with a patient.Therefore, the event has been deemed to be a reportable event.The root cause of this event was that not suitable accessories have been used.This event happened due to a user mistake.The user wanted to connect a hamilton medical breathing circuit set, dual limb with a patient-side swivel y-piece connector 15mm/id.The hamilton medical flow sensor /fs (15mmod) was connected properly to the swivel y-piece by the user.The user selected a mask with a 22mmid for the child.An adapter to connect the flow sensor 15mm od to a 22mm id mask was not available.The preparations were not done properly, otherwise the lack of a connector possibility would have been noticed before.If an hmef ( heat and moisture exchanger filter) with smaller deadspace for a 9 kg child or a catheter mount with small deadspace was available, no further adapter would have been required.We have a labelled breathing circuit set, which has the industry standard 15mm connector according to iso 5356-1.This means, a mask with industry standard 22mm connectors will not fit.All required consumables for ventilation have to be available and checked for compatibility for all different patient groups by endusers in preclinical ventilation.In consequence (correction) the ventilator was changed and an alternative tubing system was used.A capa will not need to be initiated.Nevertheless, the failures of devices in the market are monitored regularly and if the failure rate was to increase, a capa will be considered.
Event or Problem Description
The following was reported to hamilton medical ag: this event was reported to hamilton as the breathing circuit set could not be connected to the cpap mask (for children).This occurrence was noticed when the patient needed to be connected for ventilation.As a result of struggling to connect the breathing mask to the breathing circuit, some ventilator alarms were activated.The device log files were not provided to hamilton.There is patient involvement reported (infant, 20 months old, 9kg).There was need for medical intervention reported.The ventilator device and the breathing circuit set got replaced.Neither harm to the patient, user or third party has been reported.There is no delay in treatment reported as such but based on the information what has been reported, it can be concluded that this event caused a certain degree of uncertainty between the hospital staff.The investigation is ongoing.
Event or Problem Description
The following was reported to hamilton medical ag: - this event was reported to hamilton as the breathing circuit set could not be connected to the cpap mask (for children).- this occurrence was noticed when the patient needed to be connected for ventilation.- as a result of struggling to connect the breathing mask to the breathing circuit, some ventilator alarms were activated.- the device log files were not provided to hamilton.- there is patient involvement reported (infant, 20 months old, 9kg).- there was need for medical intervention reported.The ventilator device and the breathing circuit set got replaced.- neither harm to the patient, user or third party has been reported.There is no delay in treatment reported as such but based on the information what has been reported, it can be concluded that this event caused a certain degree of uncertainty between the hospital staff.The investigation is ongoing.
Additional Manufacturer Narrative
Hamilton medical ag case number is (b)(4).Investigation stil ongoing.A detailed investigation was performed by an expert from the technical service: with this investigation it has been confirmed that the device worked as intended at the time of the event.The affected breathing circuit set (neonatal) could not be connected to the cpap mask (for children) due to a different diameter of the mask.This occurrence was noticed when the patient needed to be connected for ventilation during transportation.As a result of struggling to connect the breathing mask to the breathing circuit, there were operational uncertainties.There is patient involvement reported (infant, 20 months old, 9kg).There was need for medical intervention reported as the ventilator device and the breathing circuit set got replaced.Neither harm to the patient, user or third party has been reported.There is no delay in treatment reported as such but based on the information what has been reported, it can be concluded that this event caused a certain degree of uncertainty between the hospital staff.The issue is not likely to be serious to public health but has potential to cause a delay in treatment or an intervention (replacement of the ventilator), if it were to recur during the use with a patient.Therefore, the event has been deemed to be a reportable event.The root cause of this event was that not suitable accessories have been used.· this event happened due to a user mistake.The user wanted to connect a hamilton medical breathing circuit set, dual limb with a patient-side swivel y-piece connector 15mm/id.The hamilton medical flow sensor /fs (15mmod) was connected properly to the swivel y-piece by the user.The user selected a mask with a 22mmid for the child.An adapter to connect the flow sensor 15mm od to a 22mm id mask was not available.· the preparations were not done properly, otherwise the lack of a connector possibility would have been noticed before.If an hmef ( heat and moisture exchanger filter) with smaller deadspace for a 9 kg child or a catheter mount with small deadspace was available, no further adapter would have been required.· we have a labelled breathing circuit set, which has the industry standard 15mm connector according to iso 5356-1.This means, a mask with industry standard 22mm connectors will not fit.All required consumables for ventilation have to be available and checked for compatibility for all different patient groups by endusers in preclinical ventilation.In consequence (correction) the ventilator was changed and an alternative tubing system was used.A capa will not need to be initiated.Nevertheless, the failures of devices in the market are monitored regularly and if the failure rate was to increase, a capa will be considered.Hamilton medical ag complaint number: (b)(4).Follow-up 2 - corrected information: field d4 was updated with full udi information.Updated fields: b4, d1, d4, g6, h2, h11.

• Brand Name: BREATHING CIRCUIT SET, DUAL LIMB
• Common Device Name: BREATHING CIRCUIT SET, DUAL LIMB FOR C1/T1/T1 MILITARY/MR1
• Manufacturer (Section D): HAMILTON MEDICAL AG; via crusch 8; bonaduz, 7402 ; SZ 7402
• Manufacturer (Section G): HAMILTON MEDICAL AG; via crusch 9; bonaduz, 7402 ; SZ 7402
• Manufacturer Contact: albert beckers ; via crusch 8; bonaduz, ; SZ
• MDR Report Key: 18594401
• Report Number: 3001421318-2024-00208
• Device Sequence Number: 6810529
• Product Code: BZO
• UDI-Device Identifier: 17630002805909
• UDI-Public: (01)17630002805909(10)1900060982(11)220215(17)270214(240)260170
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: 260170
• Device Catalogue Number: 260170
• Device Lot Number: 1900060982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 01/12/2024; 01/12/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 08/23/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown