LP15,EN,SPO2,12L,EX,NIBP,CO2,TR,VR,BT,TMP,V2 Adverse Event — Malfunction (MDR 0003015876-2020-00560)
LP15,EN,SPO2,12L,EX,NIBP,CO2,TR,VR,BT,TMP,V2 Adverse Event — Malfunction (MDR 0003015876-2020-00560) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LP15,EN,SPO2,12L,EX,NIBP,CO2,TR,VR,BT,TMP,V2; Generic name: AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE; Manufacturer: PHYSIO-C
| Device | LP15,EN,SPO2,12L,EX,NIBP,CO2,TR,VR,BT,TMP,V2 |
|---|---|
| Generic name | AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE |
| Manufacturer | PHYSIO-CONTROL, INC. - 3015876 |
| Report number | 0003015876-2020-00560 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN |
| Narrative | THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD BEGIN TO BOOT UP THEN AFTER THE SCREEN HAD BEEN LIT FOR APPROXIMATELY 2 SECONDS, IT WOULD TURN OFF. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. |
| Source | openFDA MAUDE (device adverse events) |
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