MAUDE Adverse Event Report: CAREFUSION RESUS, ADLT W/MASK, 40" TBG, 6/CS; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 2K8005

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2014

Event Type  Injury  

Event Description

Customer reported 2k8005 (it also has 4251a stamped on one of the fittings.) that has a defective exhalation valve.Additional information received via email from customer on (b)(6) 2014: i don¿t know one valve from another.  i¿ve attached a couple of photos to show which valve is believed to be defective.Lot # y5a1760.The sample is available for evaluation.The failure was noted when attempting to bag the patient.  a 2nd device was opened and used successfully.  no medical intervention required.

Manufacturer Narrative

(b)(4).Results of investigation: one open sample was received for evaluation.Upon observation, the broken piece (lg seal holder w/thread) was observed.The resuscitation bag could not function.This product was manufactured on 2005; the internal manufacturing records are no longer available review.Manufacturing process was reviewed and no non conformities were observed.Code 2k8005 is 100% tested by pressure, exhalation, and inhalation functions and the component is verified for any non-conformity by production personnel.Since internal manufacturing records were not available for review.The sample received was compared with a sample from production with an infrared spectrums scan and no discrepancies were found with the material used on the sample received.The seal holder w/thread is assembled with the bag and then is cured using an ultraviolet ¿uv- oven, it is not considered that equipment/machines are related, no corrective work orders were generated in the period of the manufacturing of this product.It¿s preventive maintenance was performed on time for uv equipment.Based on the investigation, it is not possible to determine a root cause, since there is no evidence that the broken piece occurred during the manufacturing process.This may have happened outside the manufacturing process, during handling/transportation.Carefusion will continue to trend and monitor this issue.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.(b)(4).

• Brand Name: RESUS, ADLT W/MASK, 40" TBG, 6/CS
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no85parque indust.mexicali iii; mexicali 21600 ; MX 21600
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4251373
• MDR Text Key: 5013070
• Report Number: 8030673-2014-00133
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2K8005
• Device Lot Number: Y5A1760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention