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Medical device regulation – what FDA does when it …:医疗器械监管–FDA所做的时候…
Abductor is seen leaving the hospital at 8:30 a.m. 9:00 a.m. She purchased black scrubs with a UPMC logo at the uniform store 2 blocks away 9:31 a.m. She is seen on camera entering the hospital She is seen on the PP unit and is questioned by staff. States she is visiting her sister (gave a patient name) who is pumping her breast. 12:15 p.m. Abductor approaches RN and states my sister is ready for her Motrin before she goes home (prior conversation between nurse and patient regarding taking Motrin prior to discharge). Sentinel Event: Infant Abduction * Nurse obtains the medication and performs HUGS discharge in the computer. 12:30 p.m. The nurse, mother, infant and abductor all in room when tag is cut off and final discharge occurs. RN leaves the room. 12:55 p.m. Mother goes into bathroom. Abductor has been in room watching TV and states she needs to take the baby for one final test. 12:58 p.m. Abductor is seen leaving the hospital with a large pink purse on video. Sentinel Event: Infant Abduction * 1:15 p.m. The FOB approaches nurse’s station asking when the infant would be returned so they can leave. RN immediately goes to room to see why baby isn’t there. 1:20 p.m. Search of the unit and Condition I initiated, security called and search of hospital is started, 911 activated. Description of the abductor is given. 1:41 p.m. Police on site. Media out front of hospital, overhead description of abductor and infant is overhead announced. Sentinel Event: Infant Abduction * Pittsburgh police and FBI respond and take jurisdiction of the hospital and incident command center in security. Operations command center is opened and staffed. MWH RN while searching walks to uniform store and gets the receipt of person who bought scrubs. Hospital Operator gets a call from Florida and a name is given of a suspected abductor posting on Facebook. Nurses identify abductor on camera footage in command center. Footage tracks her through the hospital on 8/22 8/23. Det
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