IMPULSE 7000DP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-02-26 for IMPULSE 7000DP manufactured by Fluke Biomedical.

Event Text Entries

[21983543] Intermittent out of tolerance defib pulse pulse measurements. E-mail received from (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5


[22324897] Background: customer claimed an impulse 7000 unit sn (b)(4) is suspect to intermittent failures in which defibrillator energy readings are out of the expected range noted in the specifications by fluke biomedical. The expected range was determined as energy reading +/- (1 percent (energy reading) + 0. 1) j by fluke biomedical. This unit was received with 2. 06 firmware version while the most updated firmware version is 2. 07. Investigation plan: after reviewing customer claims, a set of tests is designed to access the energy output reading of the suspect unit and to compare the results with the fluke biomedical specifications. As part of the standard test setup in service, we will measure the energy output of the defibrillator and the suspect unit simultaneously. We will use a lifepak defibrillator to provide different energy outputs to the impulse 7000 units. Following tests will be performed in order to reproduce intermittent failures and investigate the causes: the unit will be tested with "as found" (b)(4), i. E. , version 2. 06 at five different energy levels (10j, 50j, 100j, 250j, and 360j). This test is to examine the unit in a wide range of energy levels and expose any possible intermittent failures. ; the firmware of the suspect unit will be upgraded to version 2. 07 and the unit will be tested at five energy levels mentioned above. This test is performed to ensure that the unit performs according to the specifications with the most updated firmware version. Investigation findings: no failure was observed and all readings were in accordance with the specifications. No failure was observed and all readings were in accordance with the specifications. All data are documented in (b)(4). Conclusions: the unit passed all tests and no intermittent failure in the defibrillator energy reading was found. Since no failure was observed by two independent engineers, no further action is required and the status is "could not reproduce failure, no problem found". We suggest that customer keep the unit firmware up-to-date. Follow-up activities. At the conclusion of our investigation, the final report will be uploaded to the master control.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2921581-2013-00001
MDR Report Key3035891
Report Source07
Date Received2013-02-26
Date of Report2013-02-19
Date of Event2013-01-22
Date Mfgr Received2013-01-22
Date Added to Maude2013-05-03
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 Location0
Manufacturer ContactTHERESA MYERS
Manufacturer Street6920 SEAWAY BLVD.
Manufacturer CityEVERETT WA 98203
Manufacturer CountryUS
Manufacturer Postal98203
Manufacturer Phone4254466047
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPULSE 7000DP
Generic NameIMPULSE 7000DP
Product CodeDRL
Date Received2013-02-26
Returned To Mfg2013-01-22
Model Number7000DP
Catalog Number7000DP
Lot NumberNA
ID NumberNA
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerFLUKE BIOMEDICAL
Manufacturer Address6920 SEAWAY BLVD. EVERETT WA 98203 US 98203


Patients

Patient NumberTreatmentOutcomeDate
10 2013-02-26

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