MAUDE Adverse Event Report:; MRI TRANSPORT CIRCUIT

Model Number 9317

Device Problem Misconnection (1399)

Patient Problems Arrhythmia (1721); Low Oxygen Saturation (2477)

Event Date 01/23/2014

Event Type  Other  

Event Description

Mri circuit was incorrectly connected to pt resulting in arrythmia and desaturation of pt.Pt was then bagged with resuscitation and o2 level rose to normal.This is how the original complaint was reported by (b)(6) to westmed.This medwatch is a response of a maude event report no.(b)(4) submitted (b)(6).

Manufacturer Narrative

Per attached operating instructions label pn 75282 explained how to attach the circuit pursuant to standard operating protocol under "suggested use, step 1".There is a section specifically for the peep valve operating instructions and cautions and warning such as "all users of this device should read instructions for use of the circuit and associated transport equipment." as a result of this complaint and is order to make the instruction and the device more clear to operate, it was added a label to the peep valve with big arrows defining well the tubing connection and pt connection are, this way, even though the user doesn't read the instruction for use, it will be visible and evident how to attach the circuit and the proper way to hook up the connectors correctly.

• Brand Name: NA
• Type of Device: MRI TRANSPORT CIRCUIT
• Manufacturer Contact: luis burgos ; 5580 s. nogales highway; tucson, AZ 85706 ; 5202947987
• MDR Report Key: 3690750
• MDR Text Key: 4303359
• Report Number: 2028807-2014-00001
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 9317
• Device Lot Number: 08272013401
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization