MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-27 for RECHARGEABLE BATTERY FOR CARDIAC MONITOR 5603 manufactured by R&d Batteries.
[4335816]
Critically ill pt on mechanical ventilation was transported from medical unit to radiology for a ct scan. Pt on cardiac monitor and was accompanied by physician assistant and respiratory therapist. Cardiac monitor reportedly went off and on intermittently and at times showed a blank screen. Pt was subsequently determined to be asystolic, code 99 was called but was unsuccessful. Bio-medical engineering determined that the rechargeable battery in the portable cardiac monitor was faulty with loose connection and caused the monitor to go off and on while in motion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3702068 |
| MDR Report Key | 3702068 |
| Date Received | 2014-02-27 |
| Date of Report | 2014-02-27 |
| Date of Event | 2014-02-19 |
| Date Facility Aware | 2014-02-21 |
| Report Date | 2014-02-27 |
| Date Reported to Mfgr | 2013-02-27 |
| Date Added to Maude | 2014-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RECHARGEABLE BATTERY FOR CARDIAC MONITOR |
| Generic Name | NONE |
| Product Code | MOY |
| Date Received | 2014-02-27 |
| Model Number | 5603 |
| Catalog Number | 5603 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 22 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | R&D BATTERIES |
| Manufacturer Address | 3300 CORPORATE CENTER DRIVE BURNSVILLE MN 55306 US 55306 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-02-27 |