MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC VENTILATORS VENTIPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	130003
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Hyperventilation (1910); Low Oxygen Saturation (2477)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1.Initial reporter occupation unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the device failed to alarm.The patient was intubated and mechanically ventilated.Patient completed mri with instances of overbreathing and asynchrony noted.Patient was transferred from mri bed to icu bed in mri waiting area when oxygen desaturation event to 70s occurred.The device was attached to mri oxygen supply and functioning with fio2 50%.Oxygen saturation did not improve and fio2 increased to 100% with the device still functioning.Oxygen saturation did not improve.Patient was removed from the device and manually bagged until oxygen saturation improved to 100%.Patient was placed back on the device and "low supply charge" light began flashing with no discernable function.Patient was manually bagged by rn while the device was being checked.Oxygen connections tight and circuit appropriately connected.Patient maintained oxygen saturations during transport back to room.The device connected to wall o2 in icu and checked for function." low supply charge" light flashing and no detectable function observed.There was delay of treatment.Harm reported was low o2 sat for unspecified time.There was patient involvement and patient harm not significant reported.
Additional Manufacturer Narrative
One device was received for service.Complaint was device failed to alarm and low o2 sat for an unspecified time.Service request indicates that device was determined to be beyond economical repair.The device was returned to the customer.No additional information provided in record beyond this.This device is unavailable for investigation and probable cause of reported malfunction cannot be determined.

• Brand Name: PNEUPAC VENTILATORS VENTIPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19610753
• Report Number: 3012307300-2024-05473
• Device Sequence Number: 6335206
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: (01)10610586038259(11)1100712
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K030803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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 Catalogue Number: 130003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2010
• 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: Hospitalization
• Patient Sex: Unknown