TRUECPR? TRUECPR? COACHING DEVICE 3309630

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,06 report with the FDA on 2014-03-18 for TRUECPR? TRUECPR? COACHING DEVICE 3309630 manufactured by Physio-control, Inc.

Event Text Entries

[4301152] During a post-market evaluation study on the truecpr coaching device the customer reported that the palm of their hands were not comfortable on the sternum pad during use, making it uncomfortable to the user. The customer also reported that they felt it was difficult to reach the appropriate compression depth. After a review of the device data download, it was observed that although proper compression depth was being achieved, the device was indicating that the depth was too shallow which would prompt the user to push harder to achieve a deeper compression depth. There was patient use associated however, details and the outcome of the patient was not reported.
Patient Sequence No: 1, Text Type: D, B5


[11669031] (b)(4). Physio-control has investigated and verified the reported issue. Physio has determined that the cause of the reported issue is due to inaccurate depth measurement displayed by the device as a result of a combination of factors relating to user hand placement and patient anatomy. Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56.
Patient Sequence No: 1, Text Type: N, H10


[20262700] Physio-control has performed additional clinical and engineering analysis of the reported compression depth feedback accuracy issue, and through the course of that investigation has determined that the device is operating within its product requirements and specifications. It was also determined that the current product design meets established user needs and achieves a coaching benefit to the user for delivery of cardiopulmonary resuscitation (cpr) therapy. Physio-control has investigated the reported issue of inaccurate depth measurement and has verified the issue. Physio has determined that the cause of the reported issue is the result of a combination of factors relating to user hand placement and patient anatomy.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3015876-2014-00264
MDR Report Key3685195
Report Source01,02,05,06
Date Received2014-03-18
Date of Report2014-02-17
Date of Event2013-09-09
Date Mfgr Received2014-06-24
Device Manufacturer Date2013-04-17
Date Added to Maude2014-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactJASON MARCH
Manufacturer Phone4258674000
Manufacturer G1PHYSIO-CONTROL, INC
Manufacturer Street11811 WILLOWS ROAD NE PO BOX 97006
Manufacturer CityREDMOND WA 98073970
Manufacturer CountryUS
Manufacturer Postal Code98073 9706
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRUECPR?
Generic NameAID, CARDIOPULMONARY RESUSCITATION
Product CodeLIX
Date Received2014-03-18
Model NumberTRUECPR? COACHING DEVICE
Catalog Number3309630
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age11 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPHYSIO-CONTROL, INC
Manufacturer Address11811 WILLOWS ROAD NE PO BOX 97006 REDMOND WA 98073970 US 98073 9706


Patients

Patient NumberTreatmentOutcomeDate
10 2014-03-18

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