MAUDE Adverse Event Report: TX027 TX-JACKSONVILLE-MCKNIGHT CANISTER 1200CC GUARDIAN; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	65651-212
Health Effect - Clinical Code	Death (1802)
Date of Event	07/03/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Complaint forwarded to the manufacturing site for investigation.A follow-up report will be filed once sample is evaluated and the investigation completed.
Event or Problem Description
While working on a patient, staff reports that the suction was working, then stopped.The patient did pass away, but hospital has reported that they believe the patient death was not as a result of the suction canister.It did delay suctioning in the mouth of the patient after intubation, but hospital has reported patient coded a second time at a later time.
Additional Manufacturer Narrative
No lot number was provided by the customer; therefore, a review of the manufacturing device history record to determine if any deviations took place during the manufacture of the product could not be performed.One sample was received for evaluation.A visual examination of the canister was completed by quality and engineering management.No visual non-conformities were noted.Functional testing of the returned sample and five samples from our current inventory was completed by our laboratory personnel to determine the flow and leak rate.All units functioned as designed.Based on the investigation and testing of the returned sample, no specific assignable cause can be determined as the returned unit functioned as designed.Without a specific assignable cause, no specific corrective actions can be completed; however, we will continue to monitor concerns such as these for possible future actions.Key production and quality personnel have been made aware of this reported incident through the investigation process.
Event or Problem Description
While working on a patient, staff reports that the suction was working, then stopped.The patient did pass away, but hospital has reported that they believe the patient death was not as a result of the suction canister.It did delay suctioning in the mouth of the patient after intubation, but hospital has reported patient coded a second time at a later time.

• Brand Name: CANISTER 1200CC GUARDIAN
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): TX027 TX-JACKSONVILLE-MCKNIGHT; 200 mcknight st.; jacksonville TX 75766
• MDR Report Key: 7737095
• Report Number: 1423537-2018-00229
• Device Sequence Number: 1050205
• Product Code: GCX
• UDI-Device Identifier: 00630140152538
• UDI-Public: 00630140152538
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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?: No
• Operator of Device: Health Professional
• Device Model Number: 65651-212
• Device Catalogue Number: 65651-212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/22/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 33 YR
• Patient Weight: 84