FDA.reportPublic FDA data

MAUDE MDR 6509277

MDR report key
6509277
Report number
1000524541-2017-00001
Event key
0
Event type
3
Date of event
2017-04-01
Date received
2017-04-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
114
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CHARLES MOORE
Address
1655 GLENGARY BAY RD. SAGLE ID 83860 US
Phone
208-208-2082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PERCUSSIONAIRECONE ASSEMBLY, BLUE, LEXAN (ACCESSORY TO IPV-1C OR IPV-2C)PERCUSSIONAIRE CORP.NHJA50521-DA50521-DWO30702 OR WO30960Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-200

Event Narratives#

N

Patient 1

B10999-D RETAINER RING INSTALLED UPSIDE DOWN SO THAT IT WOULD NOT FORM A SEAL AROUND THE B10750 CHECK VALVE FLAPPER, THUS ALLOWING SOME AIR TO ESCAPE IN THE WRONG DIRECTION THROUGH THE CHECK VALVE. ALL EMPLOYEES RESPONSIBLE FOR ASSEMBLING PARTS WITH FLAPPERS WILL BE RE-TRAINED TO ENSURE THE PARTS ARE ASSEMBLED CORRECTLY. A TEST METHOD WAS DEVELOPED TO ALLOW 100% TESTING OF THE FLAPPER VALVE FOR LEAKS.

D

Patient 1

(CUSTOMER COMPLAINT # 0798) ISSUES WITH A CONE ON PATIENT, EXPERIENCING LOSS OF SET TIDAL VOLUMES. RESPIRATORY THERAPIST HAD TO EXCHANGE CONE OUT TIMES 3. RESPIRATORY THERAPIST KEPT ONE. DID NOT SEE ANY VISIBLE CRACKS. PER GILES NO HARM TO THE PATIENT INCURRED. EVENTS ARE AS FOLLOWS: RESPIRATORY THERAPIST USING IPV IN LINE, WYE WAS REPLACED WITH THE CONE, RESPIRATORY THERAPIST OBSERVED LOOSING 250 ML PER BREATH, WHEN THE REGULAR WYE WAS REINSTALLED THE VOLUME CAME BACK. RESPIRATORY THERAPIST DETERMINED CAUSE TO BE A LEAK IN THE CONE.