MAUDE Adverse Event Report: CAREFUSION SYSTEM HYPERINFLATION BABYSAFE RESUSC; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 5404BDL1

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial e-submission: device received for evaluation and the investigation is in progress.Once the investigation is complete a follow up esubmission will be submitted.

Event Description

Customer verbally stated that the bag was inflated 1 time and no longer worked after that.Stated that there was patient involvement but could not provide the details to me.(b)(6) 2015: customer provided info regarding patient impact.States unable to provide details of patient's name."had a delay in resuscitation as we couldn't figure out why it wasn't working until we replaced with new bag and mask and then it worked fine.We were able to give positive pressure once bag was changed out.The patient had apgar's that were low at 1 minute.All i know is what i put on original complaint, which was a while ago.Bag would not inflate with proper seal and multiple tries till we took it off and changed it as baby needed oxygen.The product was connected to 10 liters/blender.Unable to provide lot number.All i know is it didn't work properly and as soon as i changed it i was able to give positive pressure to baby".

Manufacturer Narrative

(b)(4).Follow up emdr- one loose sample baby safe hyperinflation resuscitation system was sent in for the investigation.Only four parts were sent out fo the seven; the four parts received were the apl valve, 0.5 liter breathing bag, pressure gauge, and facemask.The customer was asked by customer advocacy if the remaining parts of the sample were available, however, the customer stated the remaining parts were unavailable.This consists of gas elbow, pressure tubing and oxygen tubing.Based on all of the parts received, no defects or damage to any of the four parts in the system were found.In addition, a leak test was performed on the 0.5 liter breathing bag, facemask, pressure gauge, and apl valve.All four components passed the leak test.The lot number was unknown to the customer.Two years of complaints were reviewed and no trend was identified for this product.The complaint could not be confirmed due to the lack of components received.

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: SYSTEM HYPERINFLATION BABYSAFE RESUSC
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5054324
• MDR Text Key: 25887003
• Report Number: 2242551-2015-00028
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 5404BDL1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention