MAUDE MDR 3750430

MDR report key
3750430
Report number
3750430
Event key
0
Event type
3
Date of event
2014-03-14
Date received
2014-03-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WESTMED MRI TRANSPORT CIRCUITTRANSPORT CIRCUIT W PEEP VALVEWESTMEDBYEPN 75282, REV 02963-931708272013U01 N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-2501. L

Event Narratives#

D

Patient 1

ON (B)(6) 2014, 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 PACKAGE PRE-ASSEMBLED. THE THERAPIST PLACED CIRCUIT ON TRANSPORT VENTILATOR AS PRE SET-UP, ADJUSTED TRANSPORT VENTILATOR SETTINGS TO MATCH PATIENT'S CURRENT SETTINGS AND ATTACHED CIRCUIT TO PATIENT. DURING TRANSIT, PATIENT BECAME BRADYCARDIC, THEN PULSELESS. PATIENT WAS RESUSCITATED WITH CPR AND AMBU BAG VENTILATION. PATIENT RETURNED TO THE INTENSIVE CARE UNIT AND WAS RECONNECTED TO THE (STATIONARY) VENTILATOR. PATIENT WAS EXTUBATED ON (B)(6) 2014 AND REMAINS HOSPITALIZED. 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).