WESTMED MRI TRANSPORT CIRCUIT PN 75282, REV 02 963-9317

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-25 for WESTMED MRI TRANSPORT CIRCUIT PN 75282, REV 02 963-9317 manufactured by Westmed.

Event Text Entries

[19763384] On (b)(6) 2014, an obtunded intubated patient was transported within the facility from an intensive care unit to radiology. The respiratory therapist obtained a westmed transport ventilator circuit for use on the smith's medical parapac transport ventilator to transport the patient. The circuit was in the package pre-assembled. The therapist placed circuit on transport ventilator with 100% fio2. The patient was transferred to ct table and a spot check pulse oximeter reading was 96% (was 97% prior to transport). While in the ct scanner, the patient experienced two episodes of asystole and was resuscitated using cpr, epinephrine and ambu bag ventilation. Patient returned to the intensive care unit and was reconnected to the (stationary) ventilator. On (b)(6) 2014 family decided to withdraw life support and patient expired. Our internal investigation supports our conclusion that the westmed mri transport circuit used on this patient was incorrectly preassembled in the packaging. We pulled remaining inventory of this item. Of the remaining unused inventory, three (3) mri transport circuits were found incorrectly assembled in unopened packaging, all with the same lot number. It was also discovered that another patient earlier in the day experienced a similar situation (separate report filed).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3750433
• MDR Report Key: 3750433
• Date Received: 2014-03-25
• Date of Report: 2014-03-24
• Date of Event: 2014-03-14
• Date Facility Aware: 2014-03-14
• Report Date: 2014-03-24
• Date Reported to FDA: 2014-03-24
• Date Reported to Mfgr: 2014-03-21
• Date Added to Maude: 2014-04-16
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WESTMED MRI TRANSPORT CIRCUIT
• Generic Name: TRANSPORT CIRCUIT W PEEP VALVE
• Product Code: BYE
• Date Received: 2014-03-25
• Model Number: PN 75282, REV 02
• Catalog Number: 963-9317
• Lot Number: 08272013U01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 2 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: WESTMED
• Manufacturer Address: TUCSON AZ US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death; 2. Life Threatening	2014-03-25