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

Catalog Number	130003
Medical Device Problem Codes	No Audible Alarm (1019); Failure to Cycle (1142)
Health Effect - Clinical Code	Respiratory Arrest (4461)
Date of Event	07/26/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Unknown manufacturer: a catalog number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, smiths medical corporate headquarters in oakdale, mn has been listed in sections d3.And g1.And the oakdale fda registration number has been used for the manufacture report number.B3.Date of event: unknown.No information has been provided to date.D4.Catalog number, and h4.Manufacture date are unknown; no information has been provided to date.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 there was difficulty getting a spo2 and stable heart reading on the mri monitors.The mri brick vent stopped working, and the patient coded.The nurse did a continual pulse check since the heart monitor was not stable and noticed that the vent was not making its usual ventilatory sounds.Patient was immediately pulled from the mri machine and the radio tech began bagging.Nurse kept her hand on the patient's pulse, but the pulse was lost once they were in the preparation room.Cpr was started and code blue was called.Return of spontaneous circulation (rosc) was achieved and patient was returned to the icu.The vent was taken out of service.There was patient involvement and patient harm/adverse event reported.
Event or Problem Description
Additional information was received via email informing that a 69-year-old male who suffered a motorcycle accident resulting in subarachnoid hemorrhage and multiple critical injuries.Patient was found to have anoxic brain injury, was placed on comfort measures and passed away.Mri being completed at time of event on (b)(6) 2024 and the family of patient requesting results of investigation and equipment malfunction findings.The event occured in radiology.Date of death was not provided.
Additional Manufacturer Narrative
D9: date returned to mfg.: unknown.A1, a2, a3a, b2, b5, b3, d1, d4, g4, h3, h4 and h6.Codes: updated.Investigation summary: one device was received for evaluation.The reported problem was duplicated/replicated.Can hear something rattling around inside the case enclosure.On inspection, there is damage to the front panel, gas supply indicator and battery door.When using the device on/off switch, there are no visible or audible alarms activated.However, when supplying gas to the input, the gas supply indicator activates, and the device responds to gas drive.Swapped out the battery and now the alarm bezel led's go through the initial self-test sequence.Still no audible alarm from the sounder.On closer inspection, the gas supply indicator mounting screw has become dislodged and the wiring harness for the sounder pcb has become damaged.A depleted battery and impact damage were found to be contributing to the issue.The device was not functionally tested.No action taken - due to obsolescence and lack of spare parts, we are unable to complete the service of the ventilator.Customer has requested that device be scrapped on-site after investigation.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: PNEUPAC VENTILATORS VENTIPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITH¿S MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20010876
• Report Number: 3012307300-2024-07878
• Device Sequence Number: 7247900
• Product Code: BTL
• UDI-Device Identifier: 10610586038259
• UDI-Public: (01)10610586038259(11)050914
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2005
• 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: Death; Required Intervention; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male