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 70000DP manufactured by Fluke Biomedical.
[3410661]
Intermittent out of tolerance defib pulse, pulse measurements. E-mail received from (b)(6) dated (b)(4) 2013.
Patient Sequence No: 1, Text Type: D, B5
[10641985]
Background: customer claimed an impulse 7000 unit, sn (b)(4) is suspect to intermittent failures in which defibrillator energy readings are out of the specified range noted in the specifications by fluke biomedical. The expected accuracy range was determined as (b)(4) by fluke biomedical. This unit was received with 2. 02 firmware version while the most updated firmware version is 2. 07. Investigation plan: after reviewing customer claims, a set of tests is designed to assess 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, (b)(4). Following tests will be performed in order to reproduce intermittent failures and investigate the causes. The suspect unit with "as found" firmware 2. 02 and reference unit will be tested at different energy levels ((b)(4)). This test will be performed to examine the suspect unit in a wide range of energy levels and observe any failure tendency at each level. A known working unit with "as found" firmware will be tested in the standard rest setup in service. This unit will be tested again after the firmware is replaced to version 2. 02, which was the firmware found on the customer unit initially. This test is designed to determine if the firmware itself is the cause of the fai... Intermittent failures were observed with the customer unit when tested with firmware 2. 07 installed. Failure mode was not dependent on firmware version. When failures were observed, the post attenuator resistance was larger than the cases when the unit readings were in specified range. This variance points to suspect relay in 'as found' hardware. Simple contact resistance test showed that relay was damaged. The relay was replaced and (b)(4) tests at (b)(4) energy levels ((b)(4)) were performed to ensure that failure mode could not be reproduced and the post-attenuator resistance remains steady. After completing this test, both conditions were confirmed. (b)(4). Conclusions: after completing our investigation into the intermittent, out of specification issue reported on the impulse 7000, sn (b)(4)5, it was concluded the root cause of the issue was a bad relay on the post-attenuator circuit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921581-2013-00002 |
| MDR Report Key | 3035892 |
| 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 |
| Device Manufacturer Date | 2009-11-20 |
| Date Added to Maude | 2013-05-06 |
| 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 | RP |
| 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 | 70000DP |
| Catalog Number | 70000DP |
| Lot Number | NA |
| ID Number | 1128016 |
| 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 |