MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-03-25 for LUCAS? CPR CHEST COMPRESSION SYSTEM 99576-000033 manufactured by Jolife Ab - 3005445717.
[184980028]
Physio-control contacted the customer to request additional information on the patient. The customer provided physio-control with all the available patient information. Patient fields in which information is not provided were intentionally left blank. Stryker completed a clinical review and determined that the device use may have contributed to the patient outcome, as the interruption in cpr was one minute. The users did not follow the instructions for use that state if there are interruptions, to remove the device and start manual chest compressions. By following the instructions for use the interruption in cpr is likely to be short and not, as in this case, as long as one minute. Stryker evaluated the customer's device and was unable to duplicate the reported issue. After performing an unrelated repair, proper device operation was observed. The device was subsequently returned to the customer for use. It was noted that the batteries used with the device were manufactured in 2015. Stryker recommends that batteries be replaced approximately every three years. The likely cause of the reported issue was determined to be due to user error, as the customer had not replaced the battery after the recommended 3 year life. Initial mdr mfr 0003015876-2019-01465 was originally submitted on 09/03/2019 based on awareness date (b)(6) 2019. The device evaluation was completed on (b)(6) 2020 prompting a correction and this additional report.
Patient Sequence No: 1, Text Type: N, H10
[184980029]
The customer contacted stryker to report that their device would not work during a patient event. The device indicated the battery was fully charged, however the device did not operate. The device's suction cup was placed on the patient, but the device would not operate when the continuous and 30:2 buttons were pressed. Eventually, the device was removed from the patient and manual cpr was provided. When the device would not operate and it was removed from the patient, it was plugged into the power supply, to charge the battery for 10 minutes. The device subsequently operated correctly. The interruption in cpr was estimated to be approximately 1 minute. It was delayed due to decision making around transporting without a lucas, while it was being charged. The patient did not survive the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005445717-2020-00003 |
| MDR Report Key | 9881681 |
| Report Source | FOREIGN |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-08-05 |
| Date Facility Aware | 2020-02-25 |
| Report Date | 2019-08-05 |
| Date Reported to Mfgr | 2019-08-05 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2015-05-05 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TODD BANDY |
| Manufacturer Street | 11811 WILLOWS ROAD NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4258674000 |
| Manufacturer G1 | JOLIFE AB - 3005445717 |
| Manufacturer Street | SCHEELEVAGEN 17 IDEON SCIENCE PARK |
| Manufacturer City | LUND SE-223 70 |
| Manufacturer Country | SE |
| Manufacturer Postal Code | SE-223 70 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUCAS? CPR CHEST COMPRESSION SYSTEM |
| Generic Name | COMPRESSOR, CARDIAC, EXTERNAL |
| Product Code | DRM |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2019-08-19 |
| Model Number | LUCAS |
| Catalog Number | 99576-000033 |
| Lot Number | 3015C620 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOLIFE AB - 3005445717 |
| Manufacturer Address | SCHEELEVAGEN 17 IDEON SCIENCE PARK LUND SE-223 70 SE SE-223 70 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-25 |