MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-16 for LIFEPAK(R) 9P DEFIBRILLATOR/MONITOR/PACEMAKER 99413-000034 manufactured by Physio-control, Inc. - 3015876.
[127872078]
(b)(4). Physio-control advised the customer that their device is no longer supported by physio. As a result, service and parts are no longer available. Physio-control recommended that the device be permanently removed from service and that a replacement unit be obtained. The device has not been returned to physio-control for evaluation. The cause of the reported issue could not be determined. Device not evaluated by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[127872079]
The customer, a biomedical engineer, contacted physio-control to report that their device was locked in pacing mode. The biomedical engineer further advised that when he attempted to go into the setup menu, it would only stay in the menu for approximately 2 seconds before reverting back to the home screen where it was locked in pacing mode. Additionally, the device would not power off when the power button was pressed. As a result, defibrillation was not likely possible if it were necessary. There was no patient use associated with the reported event. The biomedical engineer did not provide physio-control with the serial number of the device. Physio-control has reached out to the customer to request the serial number, however, no response has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0003015876-2018-01927 |
| MDR Report Key | 8081054 |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-16 |
| 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 | LIFEPAK(R) 9P DEFIBRILLATOR/MONITOR/PACEMAKER |
| Generic Name | DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) |
| Product Code | LDD |
| Date Received | 2018-11-16 |
| Model Number | 9P |
| Catalog Number | 99413-000034 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-11-16 |