LIFEPAK(R) CR2 DEFIBRILLATOR
Report
- Report Number
- 0003015876-2021-01490
- Event Type
- Malfunction
- Date Received
- July 30, 2021
- Date of Event
- July 9, 2021
- Report Date
- October 28, 2021
- Manufacturer
- PHYSIO-CONTROL, INC. - 3015876
- Product Code
- MKJ
- PMA / PMN Number
- P170018
- Removal / Correction Number
- 3015876-01/14/2021-001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
AN ENGINEERING INVESTIGATION HAS DETERMINED THAT DUE TO THE DESIGN OF THE LCPR2 LID SWITCH, ABSENCE OF THE LID MAGNET ALLOWS CURRENT TO FLOW FROM THE BATTERY, EVEN WHEN THE DEVICE IS IN STANDBY MODE. THIS WILL REDUCE THE LIFE OF THE BATTERY. THEREFORE, THE REPORTED ISSUE, THE LOSS OF LID/LID MAGNET, IS ASSOCIATED WITH TWO HAZARDOUS SITUATIONS: OPENING THE LID DOES NOT TURN ON THE DEVICE, AND, HIGHER THAN INTENDED CURRENT DRAW WHILE THE DEVICE IS IN STANDBY MODE RESULTS IN A PREMATURELY DEPLETED THE BATTERY. REPLACEMENT OF THE DEVICE LID SO THAT THE MAGNET IS PRESENT IN THE DEVICE ALLOWS THE LID SWITCH TO FUNCTION AS DESIGNED; TURNING ON/OFF THE DEVICE WHEN THE LID IS OPENED AND PREVENTING CURRENT DRAW WHEN THE DEVICE LID IS CLOSED. THE LPCR2 OPERATING INSTRUCTIONS HAS BEEN UPDATED TO INCLUDE ADDITIONAL TROUBLESHOOTING TIPS TO DIRECT THE CUSTOMER TO ACT WHEN DEVICE BEHAVIOR INDICATES THE LID MAGNET MAY BE MISSING. A NEW WARNING INFORMS THE CUSTOMER OF THE RISK ASSOCIATED WITH A MISSING MAGNET.
AN ENGINEERING INVESTIGATION HAS DETERMINED THAT DUE TO THE DESIGN OF THE LCPR2 LID SWITCH, ABSENCE OF THE LID MAGNET ALLOWS CURRENT TO FLOW FROM THE BATTERY, EVEN WHEN THE DEVICE IS IN STANDBY MODE. THIS WILL REDUCE THE LIFE OF THE BATTERY. THEREFORE, THE REPORTED ISSUE, THE LOSS OF LID/LID MAGNET, IS ASSOCIATED WITH TWO HAZARDOUS SITUATIONS: OPENING THE LID DOES NOT TURN ON THE DEVICE, AND, HIGHER THAN INTENDED CURRENT DRAW WHILE THE DEVICE IS IN STANDBY MODE RESULTS IN A PREMATURELY DEPLETED THE BATTERY. REPLACEMENT OF THE DEVICE LID SO THAT THE MAGNET IS PRESENT IN THE DEVICE ALLOWS THE LID SWITCH TO FUNCTION AS DESIGNED; TURNING ON/OFF THE DEVICE WHEN THE LID IS OPENED AND PREVENTING CURRENT DRAW WHEN THE DEVICE LID IS CLOSED. THE LPCR2 OPERATING INSTRUCTIONS HAS BEEN UPDATED TO INCLUDE ADDITIONAL TROUBLESHOOTING TIPS TO DIRECT THE CUSTOMER TO ACT WHEN DEVICE BEHAVIOR INDICATES THE LID MAGNET MAY BE MISSING. A NEW WARNING INFORMS THE CUSTOMER OF THE RISK ASSOCIATED WITH A MISSING MAGNET.
A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS MISSING ITS LID MAGNET. IN THIS STATE, THE DEVICE WOULD NOT DETECT THE LID BEING OPENED OR CLOSED, AND THEREFORE WOULD NOT AUTOMATICALLY POWER ON OR OFF. THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED EVENT.
A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS MISSING ITS LID MAGNET. IN THIS STATE, THE DEVICE WOULD NOT DETECT THE LID BEING OPENED OR CLOSED, AND THEREFORE WOULD NOT AUTOMATICALLY POWER ON OR OFF. THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED EVENT.
THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL. THE CUSTOMER WILL BE PROVIDED WITH A REPLACEMENT LID.
A CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS MISSING ITS LID MAGNET. IN THIS STATE, THE DEVICE WOULD NOT DETECT THE LID BEING OPENED OR CLOSED, AND THEREFORE WOULD NOT AUTOMATICALLY POWER ON OR OFF. THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1149140 | LIFEPAK(R) CR2 DEFIBRILLATOR | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | PHYSIO-CONTROL, INC. - 3015876 | CR2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |