MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA; VENTILATOR, INTENSIVE CARE

Model Number	8414000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facilty did not involve the local dräger s&s organization into any follow-up measures; a third-party service provider was instructed to do diagnosis and - if necessary - repair the device.Dräger contacted the hospital for the purpose to obtain further information.It was responded that lack of preventive maintenance was suspected to be a contributing factor in the event but additional details could not be provided by the contact person.This lack of relevant information does not allow a case-specific evaluation by the manufacturer.Dräger concludes the following: although the exact nature of the deviation remains unknown, it did not incorporate a previously unidentified or falsely assessed risk since the device posted an alarm to alert the user.There was no functional restriction described but it cannot be excluded that the ventilation performance was impaired because a temporary desaturation was reported.Further conclusions can't be made - there was no s/n transmitted and thus, age of the device and status of repairs and preventive maintenance is unknown.Neither the unique device identifier (udi) of the affected product nor the device serial number was provided to us.We will reiterate with the customer on this.If this attempt leads to an udi, we will send a follow-up report.
Event or Problem Description
It was reported that the device posted an alarm during use while the patient was experiencing a temporary oxygen desaturation.As per report, the nurse could not identify the root cause for the alarm and thus, decided to replace the device in a controlled maneuver.Patient support was bridged in manual ventilation in the meantime; the oxygen saturation went up again and no health consequences have reportedly occurred, finally.

• Brand Name: SAVINA
• Common Device Name: VENTILATOR, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 20531389
• Report Number: 9611500-2024-00464
• Device Sequence Number: 20507536
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881
• Combination Product (Y/N): N
• PMA/510(K) Number: K003068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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: 8414000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/25/2024
• 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): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown