MAUDE Adverse Event Report: TELEFLEX HUDSON DISP MANUAL RESUS, ADULT W/FLOW DIVERTER; DISP. MANUAL RESUSCITATOR

Catalog Number 45372

Device Problem Inflation Problem (1310)

Patient Problems Death (1802); Respiratory Distress (2045)

Event Date 10/23/2013

Event Type  Death  

Event Description

The event is reported as: the customer alleges that the device was used on a patient (in intensive care) with respiratory distress.The balloon of the device remained flat.Another device was used.The patient died, however, according to mr.(b)(6) (nurse anesthetist), it was not because of the incident but because of the patient's state of health.

Manufacturer Narrative

The user facility reports that the device involved in the incident was discarded.The results of the investigation are incomplete at the time of this report.

• Brand Name: HUDSON DISP MANUAL RESUS, ADULT W/FLOW DIVERTER
• Type of Device: DISP. MANUAL RESUSCITATOR
• Manufacturer (Section D): TELEFLEX; research triangle park NC 27709
• Manufacturer (Section G): TELEFLEX; 2917 weck dr.; rtp NC 27709
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; rtp, NC 27709 ; 9194334965
• MDR Report Key: 3631854
• MDR Text Key: 3988575
• Report Number: 1044475-2014-00012
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/23/2013

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
• Device Operator: Health Professional
• Device Catalogue Number: 45372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 01/10/2014
• 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): Death