IPV PERCUSSIONATOR FAMILY AND ACC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-09 for IPV PERCUSSIONATOR FAMILY AND ACC manufactured by Percussionaire Corp..

Event Text Entries

[82139375]
Patient Sequence No: 1, Text Type: N, H10


[82139376] Received call from mother of patient stating that the ipv device was not working properly. Attempted to troubleshoot equipment over the phone with no resolution. Scheduled home visit and arrived at patient's home to find ipv working for 2-3 minutes but started to slow down. Equipment replaced.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6776515
MDR Report Key6776515
Date Received2017-08-09
Date of Report2017-08-04
Date of Event2017-07-28
Report Date2017-08-04
Date Reported to FDA2017-08-04
Date Reported to Mfgr2017-08-04
Date Added to Maude2017-08-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIPV PERCUSSIONATOR FAMILY AND ACC
Generic NameDEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
Product CodeNHJ
Date Received2017-08-09
OperatorPATIENT FAMILY MEMBER OR FRIEND
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPERCUSSIONAIRE CORP.
Manufacturer Address1655 GLENGARY BAY RD SAGLE ID 83860 US 83860


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.