| Device |
dc-defibrillator, low-energy, (including paddles) |
| Regulation Description |
DC-defibrillator (including paddles). |
| Product Code | LDD |
| Regulation Number |
870.5300
|
|---|
| Device Class |
2
|
| Device Problems |
| Failure to run on AC/DC |
862 |
| Device inoperable |
460 |
| Failure to power-up |
446 |
| Failure to deliver energy |
418 |
| Device displays error message |
332 |
| Failure to charge |
250 |
| Loss of power |
121 |
| Detachment of device component |
58 |
| Output energy incorrect |
55 |
| No display or display failure |
44 |
| Device damaged prior to use |
40 |
| Component(s), broken |
36 |
| Device Issue |
35 |
| Failure to discharge |
26 |
| Incorrect display |
25 |
| Blank screen |
25 |
| Connection issue |
24 |
| Battery charger, defective |
23 |
| Delayed charge time |
19 |
| Failure to shock or properly shock |
17 |
| Failure to sense |
15 |
| Device operates differently than expected |
13 |
| Device sensing issue |
11 |
| Component missing |
11 |
| Inappropriate shock |
9 |
| Smoking |
9 |
| EKG/ECG analysis, failure to perform |
8 |
| Power source issue |
8 |
| Loose or intermittent connection |
7 |
| Fitting problem |
6 |
| Burn of device or device component |
6 |
| Break |
5 |
| Connection error |
5 |
| Failure to analyze rhythm |
5 |
| Out-of-box failure |
5 |
| Difficult or delayed activation |
5 |
| Low battery |
4 |
| Detachment of device or device component |
4 |
| Device emits odor |
4 |
| Loose |
4 |
| Failure to pace or properly pace |
4 |
| Fire |
4 |
| Displacement |
3 |
| Alarm, no lead |
3 |
| Artifact |
3 |
| Component falling |
3 |
| Use of Device Issue |
3 |
| Aborted charge |
3 |
| Charging issue |
3 |
| Failure to calibrate |
3 |
| Cable, defective |
2 |
| Intermittent shock |
2 |
| No voice prompts |
2 |
| Alarm system, failure of message-leads off |
2 |
| Incorrect interpretation of rhythm |
2 |
| Material separation |
2 |
| Calibration error |
2 |
| Battery failure |
2 |
| Electrode contact(s), problem with |
2 |
| Contamination during use |
2 |
| Intermittent continuity |
2 |
| Failure to deliver countershock |
1 |
| Difficult to deploy |
1 |
| Unintended energization |
1 |
| Shock, electrical |
1 |
| Electrode(s), failure of |
1 |
| Energy output to patient tissue incorrect |
1 |
| Energy spectrum incorrect |
1 |
| Foreign material |
1 |
| Material fragmentation |
1 |
| Insulation failure |
1 |
| Premature discharge of battery |
1 |
| Alarm, audible |
1 |
| Device alarm system issue |
1 |
| Cable break |
1 |
| Circuit Failure |
1 |
| Colony forming units |
1 |
| Shock, failure to advise |
1 |
| Failure to recalibrate |
1 |
| Difficult to position |
1 |
| Failure, intermittent |
1 |
| Melted |
1 |
| Migration of device or device component |
1 |
| Monitor failure |
1 |
| Loss of threshold |
1 |
| Undersensing |
1 |
| Inaccurate synchronization |
1 |
| Shoulder rest, detachment of |
1 |
| Failure to select signal |
1 |
| Inaudible voice prompts |
1 |
| Noise |
1 |
| Arcing at electrodes |
1 |
| Defective component |
1 |
| Arcing |
1 |
| Communication or transmission issue |
1 |
| Component or accessory incompatibility |
1 |
| Computer operating system issue |
1 |
| High Readings |
1 |
| Miscalibration |
1 |
| Failure to deliver |
1 |
| Total Device Problems |
3553 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
2014 |
2015 |
2016 |
2017 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
| Class II |
0 |
3 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
