MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-08-31 for THERMOSUIT SYSTEM TSP-50 75001 manufactured by Life Recovery Systems Hd, Llc.
[2381847]
On (b)(6) 2011, the pt was brought to an outlying hospital unresponsive, apneic and pulseless after an extended period of cardiac arrest. Pt was transported by spouse. After 40 mins of cpr the pt returned to spontaneous circulation. The pt was transferred to another hospital via airlift and was taken directly to the cath lab for successful pci. Post-resuscitation therapeutic hypothermia per aha guidelines was prescribed. The pt was posturing prior to cooling. Cooling was initiated with the thermosuit system with a target pt temperature of 33 degrees c. The pt was cooled for approx 80 mins, during which the pt temperature did not change on the thermosuit system. It was determined that the thermosuit system had malfunctioned and displayed an inaccurate pt temperature. Although the thermosuit system displayed 39 degrees c, the actual pt temperature using a different monitor was 28. 5 degrees c. Active rewarming was initiated. The pt went into cardiac arrest, then rec'd cpr, however was unresponsive. The hospital physicians indicated that the cause of death was the underlying disease and prolonged period of cardiac arrest rather than the pt over cooling.
Patient Sequence No: 1, Text Type: D, B5
[9517029]
Device is manufactured for life recovery systems by subcontract mfr, nexcore technology, inc. , (b)(4). Device eval conducted by nexcore.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006059109-2011-00001 |
| MDR Report Key | 2234191 |
| Report Source | 05 |
| Date Received | 2011-08-31 |
| Date of Event | 2011-08-01 |
| Date Mfgr Received | 2011-08-01 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2011-09-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RICHARD HETTENBACH |
| Manufacturer Street | 170 KINNELON RD. |
| Manufacturer City | KINNELON NJ 07405 |
| Manufacturer Country | US |
| Manufacturer Postal | 07405 |
| Manufacturer Phone | 9732832800 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMOSUIT SYSTEM |
| Generic Name | THERMAL REGULATING SYSTEM |
| Product Code | NZE |
| Date Received | 2011-08-31 |
| Returned To Mfg | 2011-08-10 |
| Model Number | TSP-50 |
| Catalog Number | 75001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFE RECOVERY SYSTEMS HD, LLC |
| Manufacturer Address | 170 KINNELON RD KINNELON NJ 07405 US 07405 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2011-08-31 |