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.
[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
| Report Number | 2921581-2013-00001 |
| MDR Report Key | 3035891 |
| Report Source | 07 |
| Date Received | 2013-02-26 |
| Date of Report | 2013-02-19 |
| Date of Event | 2013-01-22 |
| Date Mfgr Received | 2013-01-22 |
| Date Added to Maude | 2013-05-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | THERESA MYERS |
| Manufacturer Street | 6920 SEAWAY BLVD. |
| Manufacturer City | EVERETT WA 98203 |
| Manufacturer Country | US |
| Manufacturer Postal | 98203 |
| Manufacturer Phone | 4254466047 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPULSE 7000DP |
| Generic Name | IMPULSE 7000DP |
| Product Code | DRL |
| Date Received | 2013-02-26 |
| Returned To Mfg | 2013-01-22 |
| Model Number | 7000DP |
| Catalog Number | 7000DP |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FLUKE BIOMEDICAL |
| Manufacturer Address | 6920 SEAWAY BLVD. EVERETT WA 98203 US 98203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-26 |