MAUDE Adverse Event Report: VITAL SIGNS CODE BLUE RESUSCITATORS; VENTILATOR, EMERGENCY, MANUAL (RESUS

Model Number 7550E

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  No Answer Provided  

Event Description

Customer stated anesthesia brought over a patient that had been deprived of o2, he stated there was no way of knowing if o2 was flowing or not since the product had a tail hose reservoir type and he didn't like the corrugated hose.

Manufacturer Narrative

No patient info has been provided.Block a3: actual date of event was not reported.Patient outcome unknown.Add'l info to determine device function is unavailable at this time.Carefusion has made several documented attempts for add'l info regarding the event reported.Investigation is ongoing.A f/u report will be submitted once the investigation has been completed.

• Brand Name: CODE BLUE RESUSCITATORS
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUS
• Manufacturer (Section D): VITAL SIGNS; totowa NJ
• Manufacturer (Section G): VITAL SIGNS; totowa NJ
• Manufacturer Contact: jill rittorno, rn, bsn ; 75 n. fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3716710
• MDR Text Key: 4253101
• Report Number: 2242551-2014-00001
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7550E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other