RESQPUMP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-03-02 for RESQPUMP manufactured by .

Event Text Entries

[137700641] The pump arrived with signs of normal wear and tear. There was no indication of modification or misuse of the device. The clicking upon decompression was confirmed as reported. The clamshell was opened to get access to the spring subassembly hole. Although the micrometer had to be held at a slight angle, the measurements were consistent (11. 12, 11. 18, 11. 29 and 11. 17) and all well below the current specification of 12. 4 +/- 0. 1 mm. This issue was addressed in late 2015. Reference engineering evaluation report # (b)(4). The correction for the clicking was to widen the spring subassembly hole and rev the drawing to indicate this dimension as critical. Refer to change order (b)(4). This pump was built prior to implementation of the new drawing.
Patient Sequence No: 1, Text Type: N, H10


[137700642] This resqpump was identified during the daily check of the device and not during patient care. The resqpump is making a "clicking" noise when compressing and decompressing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003477173-2019-00001
MDR Report Key8384636
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2019-03-02
Date of Report2019-03-01
Date of Event2019-02-05
Date Mfgr Received2019-02-06
Date Added to Maude2019-03-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDIANE HOWELL
Manufacturer Street1905 COUNTY ROAD C WEST
Manufacturer CityROSEVILLE MN 55113
Manufacturer CountryUS
Manufacturer Postal55113
Manufacturer Phone6514035600
Manufacturer G1ADVANCED CIRCULATORY
Manufacturer Street1905 COUNTY ROAD C WEST
Manufacturer CityROSEVILLE MN 55113
Manufacturer CountryUS
Manufacturer Postal Code55113
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameRESQPUMP
Product CodePIZ
Date Received2019-03-02
Device Availability*
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-02

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