MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-04-11 for TEMP MNGMT CONTROL UNIT 01000-01R 991099412 manufactured by Kimberly-clark Health Care.
[4309621]
Kimberly-clark received a report stating,? The hospital owned unit has a melted fuse. This was discovered prior to use when plugging in the unit, they couldn't get it to turn on. Not used on any patients.? (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11833396]
The review of the device history record is pending. If any additional relevant information is identified following completion of the dhr review, the additional relevant information will be submitted in a follow-up report. The device was not returned to kimberly-clark for analysis, therefore we are unable to determine a root cause for this reported event. Information from this incident will be included in our product complaint and mdr trend reporting systems. Ongoing analysis of trend information is used to identify the need for additional investigations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033422-2014-00009 |
| MDR Report Key | 3741804 |
| Report Source | 06,07 |
| Date Received | 2014-04-11 |
| Date of Report | 2014-03-14 |
| Date Mfgr Received | 2014-03-14 |
| Date Added to Maude | 2014-06-05 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RA/QA AE COORDINATOR |
| Manufacturer Street | 1400 HOLCOMB BRIDGE ROAD |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer G1 | SANMINA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMP MNGMT CONTROL UNIT |
| Generic Name | PATIENT WARMING SYSTEM MODEL 1000 CONTROL UNIT |
| Product Code | JRR |
| Date Received | 2014-04-11 |
| Model Number | 01000-01R |
| Catalog Number | 991099412 |
| Lot Number | 4168 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK HEALTH CARE |
| Manufacturer Address | 1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-11 |