MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER manufactured by Polymer Technology Systems Inc.
[130984940]
Device: cardiochek plus analyzer machine was turned on for brief period (10 minutes or less) and then turned off. This was during a training, so no patient was harmed. While machine was turned off, it began heating up and became hot to the touch. The battery cover was opened (4 aa batteries are used) and the batteries were melting and became molten. The employee was able to remove the batteries without injury, but afterwards the aa batteries exploded. This is our third device to overheat in 2018, but first time that the batteries have become molten and exploded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082217 |
| MDR Report Key | 8175532 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-12-12 |
| Date Added to Maude | 2018-12-18 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER |
| Generic Name | SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN |
| Product Code | MRR |
| Date Received | 2018-12-17 |
| Returned To Mfg | 2018-12-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POLYMER TECHNOLOGY SYSTEMS INC |
| Manufacturer Address | INDIANAPOLIS IN 46268 US 46268 |
| Brand Name | PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER |
| Generic Name | SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN |
| Product Code | MRR |
| Date Received | 2018-12-17 |
| Returned To Mfg | 2018-12-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | POLYMER TECHNOLOGY SYSTEMS INC |
| Manufacturer Address | INDIANAPOLIS IN 46268 US 46268 |
| Brand Name | PTS DIAGNOSTICS CARDIOCHEK PLUS ANALYZER |
| Generic Name | SYSTEM, TEST, LOW DENSITY, LIPOPROTEIN |
| Product Code | MRR |
| Date Received | 2018-12-17 |
| Returned To Mfg | 2018-12-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | POLYMER TECHNOLOGY SYSTEMS INC |
| Manufacturer Address | INDIANAPOLIS IN 46268 US 46268 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-17 |