MAUDE Adverse Event Report: MERCURY MEDICAL MERCURY MEDICAL CPR BAG; DEVICE, CARDIOPULMONARY RESUSCITATION

Catalog Number 1056238 (INFANT)

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Death (1802)

Event Date 02/10/2016

Event Type  Death  

Event Description

A (b)(6) patient presented to the ed unresponsive.The child was brought in by their mother after being found unresponsive.The child is one of twins born two months premature and was initially intubated in the nicu.Per the mother, she was checking on the baby and the baby was not breathing.The timeframe from the last known breathing state may have been up to an hour.There is no history of trauma and the child had not been otherwise recently ill.On the ed crash cart there are three different size cpr bags: adult, child and infant.The packaging is all the same regardless of size with little distinction between products; they are simply in a blue plastic bag with a drawstring.This poses a significant human factors issue as fast, easy identification of emergency medical devices is imperative in time sensitive scenarios.The use of different colored packaging or improved labeling should be considered to prevent potential harm.

• Brand Name: MERCURY MEDICAL CPR BAG
• Type of Device: DEVICE, CARDIOPULMONARY RESUSCITATION
• Manufacturer (Section D): MERCURY MEDICAL; 11300 49th st north; clearwater FL 33762
• MDR Report Key: 5450344
• MDR Text Key: 38637897
• Report Number: 5450344
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 1056238 (INFANT)
• Other Device ID Number: 1056063 (ADULT), 1056148 (CHI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2016
• 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): Death; Hospitalization; Life Threatening; Other; Required Intervention; Disability