MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-30 for QUIK-COMBO ELECTRODES WITH REDI-PAK PRE-CONNECT SYSTEM 11996-000017 manufactured by Physio-control, Inc. - 3015876.
[129189373]
(b)(4). Physio-control performed an initial test of the provided defibrillation electrodes and was unable to reproduce the reported issue. 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
[129189374]
The customer contacted physio-control to report that their defibrillation electrode did not recognize a patient's ecg when used with either a lifepak 20 defibrillator/monitor or a lifepak 20e defibrillator/monitor. The device showed a dashed line with the defibrillation electrodes connected to the patient. When the electrodes were replaced, the device did recognize the patient's ecg through these new electrodes and functioned properly. There was patient use associated with the reported issue, but no patient information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0003015876-2018-02015 |
| MDR Report Key | 8120976 |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2018-11-02 |
| Device Manufacturer Date | 2018-08-06 |
| Date Added to Maude | 2018-11-30 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MEG MARSEGLIA |
| Manufacturer Street | 11811 WILLOWS ROAD NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4258674000 |
| Manufacturer G1 | PHYSIO-CONTROL, INC. - 3015876 |
| Manufacturer Street | 11811 WILLOWS ROAD NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | QUIK-COMBO ELECTRODES WITH REDI-PAK PRE-CONNECT SYSTEM |
| Generic Name | ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION |
| Product Code | MLN |
| Date Received | 2018-11-30 |
| Returned To Mfg | 2018-11-27 |
| Model Number | NA |
| Catalog Number | 11996-000017 |
| Lot Number | 823217 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHYSIO-CONTROL, INC. - 3015876 |
| Manufacturer Address | 11811 WILLOWS ROAD NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-30 |