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

Catalog Number 2K8005

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr submission-customer advocacy has reached out to customer to provide sample for the investigation.The actual affected sample was disposed of; the customer is sending a comparison sample and it is currently in transit.At this time we are currently waiting for the sample.Once the investigation is complete or if we receive any additional information we will provide a follow up emdr.

Event Description

The customer reported the following: ¿today we had an issue with an airlife manual resuscitator.The bag had not been used for several days at least.They took the patient off to bag him before a travel, as a test because he was on high support.He had desaturations with manual ventilation.This was repeated several times."the patient only desaturated to about 85%, the therapist was at the bedside troubleshooting and quickly observed the issue and replaced the manual resuscitator." the therapist noticed the exhalation valve looked funny.She removed the peep valve and the exhalation valve fell out onto the floor.The exhalation flapper valve (white disc) folded over and fell out when peep valve attached was removed".They replaced it with a new bag and went on the travel after ensuring stability in the patient.The sample being returned for evaluation will be a companion sample.The resuscitator involved in the incident was disposed of by the customer.

Manufacturer Narrative

(b)(4).Follow up emdr with device evaluation summary.The device history record for the reported lot number was evaluated for any issues related with this customer report, and no issues were observed.One representative sample was received for evaluation with a lot number of 0000879588.During our visual inspection no issues were found.Functional inspections were also performed to the unit (pressure/leak test, pull test, solvent effectiveness, and inhalation/exhalation test) and no issues were found with the sample provided.Based on the investigation, at this time the issue reported on this product could not be confirmed.The sample provided was evaluated and did not present any anomalies.At this time no corrective action will be implemented since the issue reported was not confirmed.(b)(4).

• Brand Name: RESUS, ADLT W/MASK, 40" TBG, 6/CS
• Type of Device: MANUAL EMERGENCY VENTILATOR
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte IL ; MX
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 5689650
• MDR Text Key: 46257756
• Report Number: 8030673-2016-00173
• Device Sequence Number: 1
• Product Code: OEV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2K8005
• Device Lot Number: 0000799588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention