LIFEPAK(R) CR2 DEFIBRILLATOR
Report
- Report Number
- 0003015876-2019-00360
- Event Type
- Death
- Date Received
- March 2, 2019
- Date of Event
- February 3, 2019
- Report Date
- February 5, 2021
- Manufacturer
- PHYSIO-CONTROL, INC. - 3015876
- Product Code
- MKJ
- PMA / PMN Number
- P170018
- Removal / Correction Number
- 3015876-01/14/2021-001-C
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
THROUGH FURTHER INVESTIGATION, PHYSIO- CONTROL HAS DETERMINED THAT THE LIDS ARE NON- CONFIRMING TO SPECS. SPECIFICALLY, THE FLATNESS OF THE LID DOES NOT MEET THE 0.010¿ REQUIREMENT. THE LIDS ARE SLIGHTLY CURVED INSTEAD OF FLAT WHICH CHANGES THE TAB ANGLE IN REGARDS TO THE DEVICE¿S LEDGE. WHEN THE LID CLOSES, THE MAGNET RECEPTACLE CATCHES THE LEDGE AND BUMPS THE MAGNET OUT.
PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE DEVICE NOT AUTOMATICALLY POWERING ON WHEN THE LID WAS OPENED WAS DUE TO THE MAGNET MISSING FROM THE LID, WHICH CAUSED THE DEVICE TO NOT DETECT WHEN THE LID WAS OPENED. ADDITIONALLY, A USE ERROR WAS IDENTIFIED AS THE USER DID NOT FOLLOW THE LIFEPAK CR2 DEFIBRILLATOR OPERATING INSTRUCTIONS WHICH STATE IN CHAPTER 4 USING THE DEFIBRILLATOR, RESPONDING TO A SUDDEN CARDIAC ARREST EMERGENCY IN STEP 3 ¿PLACE THE DEFIBRILLATOR NEAR THE PATIENT AND ON THE SIDE NEXT TO YOU. OPEN THE LID TO TURN ON THE DEFIBRILLATOR. THE DEFIBRILLATOR WILL GUIDE YOU THROUGH THE APPROPRIATE STEPS. NOTE: IF THE DEFIBRILLATOR DOES NOT TURN ON OR THE LID IS MISSING, PRESS THE ON/OFF BUTTON.¿ THE CUSTOMER DID NOT FOLLOW THE OPERATING INSTRUCTIONS AND POWER THE DEVICE ON WITH THE ON/OFF BUTTON DURING THE PATIENT EVENT. DEVICE NOT EVALUATED BY MANUFACTURER.
SECTION E4 INITIAL REPORT SENT TO FDA OF THE INITIAL MEDWATCH REPORT INDICATES: BLANK. SECTION E4 INITIAL REPORT SENT TO FDA OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: NO.
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 HAVE 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.
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE PATIENT WAS PROVIDED WITH CARDIOPULMONARY RESUSCITATION BY POLICE OFFICERS AT THE SCENE. WHEN PARAMEDICS ARRIVED, A BACK-UP DEVICE WAS USED AND IT WAS OBSERVED THAT THE PATIENT HAD A NON-SHOCKABLE HEART RHYTHM. THE RESUSCITATION WAS EVENTUALLY TERMINATED. THE PATIENT DID NOT SURVIVE THE REPORTED EVENT. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT; HOWEVER, DUE TO PRIVACY ISSUES FURTHER INFORMATION WAS NOT PROVIDED.
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE PATIENT WAS PROVIDED WITH CARDIOPULMONARY RESUSCITATION BY POLICE OFFICERS AT THE SCENE. WHEN PARAMEDICS ARRIVED, A BACK-UP DEVICE WAS USED AND IT WAS OBSERVED THAT THE PATIENT HAD A NON-SHOCKABLE HEART RHYTHM. THE RESUSCITATION WAS EVENTUALLY TERMINATED. THE PATIENT DID NOT SURVIVE THE REPORTED EVENT. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT; HOWEVER, DUE TO PRIVACY ISSUES FURTHER INFORMATION WAS NOT PROVIDED.
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE PATIENT WAS PROVIDED WITH CARDIOPULMONARY RESUSCITATION BY POLICE OFFICERS AT THE SCENE. WHEN PARAMEDICS ARRIVED, A BACK-UP DEVICE WAS USED AND IT WAS OBSERVED THAT THE PATIENT HAD A NON-SHOCKABLE HEART RHYTHM. THE RESUSCITATION WAS EVENTUALLY TERMINATED. THE PATIENT DID NOT SURVIVE THE REPORTED EVENT. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT; HOWEVER, DUE TO PRIVACY ISSUES FURTHER INFORMATION WAS NOT PROVIDED.
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE PATIENT WAS PROVIDED WITH CARDIOPULMONARY RESUSCITATION BY POLICE OFFICERS AT THE SCENE. WHEN PARAMEDICS ARRIVED, A BACK-UP DEVICE WAS USED AND IT WAS OBSERVED THAT THE PATIENT HAD A NON-SHOCKABLE HEART RHYTHM. THE RESUSCITATION WAS EVENTUALLY TERMINATED. THE PATIENT DID NOT SURVIVE THE REPORTED EVENT. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT; HOWEVER, DUE TO PRIVACY ISSUES FURTHER INFORMATION WAS NOT PROVIDED.
THROUGH FURTHER INVESTIGATION, PHYSIO-CONTROL HAS DETERMINED THAT THE LIDS ARE NON-CONFORMING TO SPECS. SPECIFICALLY, THE FLATNESS OF THE LID DOES NOT MEET THE 0.010¿ REQUIREMENT. THE LIDS ARE SLIGHTLY CURVED INSTEAD OF FLAT WHICH CHANGES THE TAB ANGLE IN REGARDS TO THE DEVICE¿S LEDGE. WHEN THE LID CLOSES, THE MAGNET RECEPTACLE CATCHES THE LEDGE AND BUMPS THE MAGNET OUT. PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE DEVICE NOT AUTOMATICALLY POWERING ON WHEN THE LID WAS OPENED WAS DUE TO THE MAGNET MISSING FROM THE LID, WHICH CAUSED THE DEVICE TO NOT DETECT WHEN THE LID WAS OPENED. ADDITIONALLY, A USE ERROR WAS IDENTIFIED AS THE USER DID NOT FOLLOW THE LIFEPAK CR2 DEFIBRILLATOR OPERATING INSTRUCTIONS WHICH STATE IN CHAPTER 4 USING THE DEFIBRILLATOR, RESPONDING TO A SUDDEN CARDIAC ARREST EMERGENCY IN STEP 3 ¿PLACE THE DEFIBRILLATOR NEAR THE PATIENT AND ON THE SIDE NEXT TO YOU. OPEN THE LID TO TURN ON THE DEFIBRILLATOR. THE DEFIBRILLATOR WILL GUIDE YOU THROUGH THE APPROPRIATE STEPS. NOTE: IF THE DEFIBRILLATOR DOES NOT TURN ON OR THE LID IS MISSING, PRESS THE ON/OFF BUTTON.¿ THE CUSTOMER DID NOT FOLLOW THE OPERATING INSTRUCTIONS AND POWER THE DEVICE ON WITH THE ON/OFF BUTTON DURING THE PATIENT EVENT.
(B)(4). THE CUSTOMER CONFIRMED THAT WHEN THE DEVICE WAS LATER RETRIEVED IT WAS OBSERVED THAT THE MAGNET OF THE LID WAS MISSING. THEREFORE THE DEVICE WOULD NOT DETECT THE LID BEING OPENED AND WOULD NOT AUTOMATICALLY POWER ON WHEN THE LID WAS OPENED. THE DEVICE WAS OBSERVED TO BE ABLE TO BE POWERED ON BY PRESSING THE ON/OFF BUTTON. PHYSIO-CONTROL WAS PROVIDED WITH LIMITED INFORMATION, DUE TO PRIVACY ISSUES. THEREFORE, A CLINICAL REVIEW DETERMINED THAT IT IS UNKNOWN WHETHER THE USAGE OF THE DEVICE CONTRIBUTED TO THE OUTCOME OF THE PATIENT. 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.
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE PATIENT WAS PROVIDED WITH CARDIOPULMONARY RESUSCITATION BY POLICE OFFICERS AT THE SCENE. WHEN PARAMEDICS ARRIVED, A BACK-UP DEVICE WAS USED AND IT WAS OBSERVED THAT THE PATIENT HAD A NON-SHOCKABLE HEART RHYTHM. THE RESUSCITATION WAS EVENTUALLY TERMINATED. THE PATIENT DID NOT SURVIVE THE REPORTED EVENT. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT; HOWEVER, DUE TO PRIVACY ISSUES FURTHER INFORMATION WAS NOT PROVIDED.
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE PATIENT WAS PROVIDED WITH CARDIOPULMONARY RESUSCITATION BY POLICE OFFICERS AT THE SCENE. WHEN PARAMEDICS ARRIVED, A BACK-UP DEVICE WAS USED AND IT WAS OBSERVED THAT THE PATIENT HAD A NON-SHOCKABLE HEART RHYTHM. THE RESUSCITATION WAS EVENTUALLY TERMINATED. THE PATIENT DID NOT SURVIVE THE REPORTED EVENT. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT; HOWEVER, DUE TO PRIVACY ISSUES FURTHER INFORMATION WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177836 | LIFEPAK(R) CR2 DEFIBRILLATOR | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | PHYSIO-CONTROL, INC. - 3015876 | CR2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |