Codeblue
Reports indicate the end user was transported to the area burn center where they eventually succumbed and died after suffering 3rd degree burns over 85% of their body.
Codeblue- Burn
Conclusion:
61-User Error- 1 device.
18- Failure to instructions- 1 device
Delete it
GE Healthcare (GEHC) reported a field modification for this issue per 21 CFR 806 on 04 MAY 2022. The FDA Recall numbers are Z-1285-2022 and Z-1286-2022.
806 Recall
Patient ID's/ Sample ID's
(B)(6).
What is the name of the toy cowboy in Toy Story movie?
Woody
It was alleged that the patient's personal diabetes manager (PDM) battery melted/exploded while charging it causing the PDM to catch fire.
Codeblue- Fire
Missing information from this report is identified as Blank; this information was not provided in the reported event or available at the time of report submission.
Delete
For what kind of report should you check image for the word "scope" to identify if it is reportable or not.
Olympus/Pentax/Fujifilm
Patient locating address outside the United States
(B)(6).
Which school did Harry Potter attend?
Hogwarts
An incident affecting more than one individual arising from a single device and event, and it is not a malfunction event.
Multiple injury
Results/Conclusion/Method codes with definition
Delete
Is this reportable? What kind of reportable event is this?
"Collection retro prothetic with nodules pictures enhanced after injection. Non-contributory biopsy. Radiologist suspects ALCL. Device was in bad condition".
NOT a reportable ALCL
Voluntary report number: MW5112250
Keep it
Who was the first American president?
George Washington
A facility reported a Microsensor was placed in a 20 year old patient on an unknown date... The patient died 2 days later, he herniated.
Pediatric death
5-Day, Pediatric and multiple should be processed within ______ hour.
one
This Medwatch report is in response to receipt of Voluntary Medwatch Report with Patient Identifier C457154
Possible Linking
Based on the severity of harm and likelihood of occurrence, the risk associated to the hazardous situation is deemed acceptable since the calculated complaint occurrence rate 0.00007% is below 0.01% likelihood of occurrence.
Redact "0.00007% is below 0.01%" as (B)(4)
The smallest state in America
Rhode Island
An event that resulted in death due to an allergic reaction, where shortness of breath/difficulty breathing along with rash or swelling occurred
Anaphylaxis
TRIAGE system in order
Codeblue, Death, Injury, voluntary, UF/Medsun, Importer, Malfunction, Supplementals
Patient was diagnosed with Mycobacterium chimaera infection (Tested postitive for bacteria) and __________ (brand name) was used.
3T Heater cooler
Lot 1811490: 15 items manufactured and released on 01/25/2020. Expiration date: 5/15/2025. No anomalies found related to the problem. To date 9 items of the same lot have been sold without any similar reported event.
Redact "15 items" and "9 items" as (B)(4)
Hawaii and Arizona