MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-24 for KING OF HEARTS EXPESS AF manufactured by Life Watch Services.
[3664171]
Three defective "king of hearts express af" cardiac event monitors. On (b)(6) 2013 my cardiologist ordered service from (b)(6). I received via (b)(6) a device. Two days later it failed. Showed error code "e-0009" on screen. Reported it to (b)(6). Clinical staff on several occasions knew they were defective. Supposed to be 30 days. They stopped service due to my contacting fda. They retaliated. Device failed on (b)(6) 2013. Replacement sent. Device failed on (b)(6) 2013. Third replacement sent. Device failed on (b)(6) 2013. Fourth device sent (b)(6) stopped mid-shipment by (b)(6) in retaliation for my contacting fda, a protected activity under 31 u. S. C. 3730 for violations of 31 u. S. C. 3729, and returned to (b)(6) tracking number (b)(6). (b)(6) prematurely terminated service because i reported them to fda for sending me three defective cardiac event devices from (b)(6) 2013 all returned via (b)(6). Sent by (b)(6) to me. I have congestive heart failure (chronic) stents in place, and life threatening. A fib and spvt (tachycardia) up to 200 plus beats/minute. This company robbed (b)(6) and settled a false claims suit in federal court in (b)(6). This company was warned by fda on 12/17/2012 about sending "adulterated" devices. They continue to violate the law. Warning letter sent 12/17/2012 by fda (b)(4) office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5031074 |
| MDR Report Key | 3252331 |
| Date Received | 2013-07-24 |
| Date of Report | 2013-07-16 |
| Date of Event | 2013-05-19 |
| Date Added to Maude | 2013-07-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KING OF HEARTS EXPESS AF |
| Generic Name | CARDIAC MONITOR |
| Product Code | DXH |
| Date Received | 2013-07-24 |
| Returned To Mfg | 2013-06-15 |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFE WATCH SERVICES |
| Manufacturer Address | ROSEMONT IL 60018 US 60018 |
| Brand Name | KING OF HEARTS EXPERSS AF |
| Generic Name | CARDIAC MONITOR |
| Product Code | DXH |
| Date Received | 2013-07-24 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | LIFEWATCH SERVICES |
| Manufacturer Address | ROSEMONT IL 60018 US 60018 |
| Brand Name | KING OF HEARTS EXPRESS AF |
| Generic Name | CARDIAC MONITOR |
| Product Code | DXH |
| Date Received | 2013-07-24 |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | LIFEWATCH SERVICES |
| Manufacturer Address | ROSEMONT IL 60018 US 60018 |
| Brand Name | KING OF HEARTS EXPRESS AF |
| Generic Name | CARDIAC MONITOR |
| Product Code | DXH |
| Date Received | 2013-07-24 |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | LIFEWATCH SERVICES |
| Manufacturer Address | ROESEMONT IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2013-07-24 |