MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-06-08 for MTS 24 PLACE CENTRIFUGE MTS515060 manufactured by Micro Typing Systems, Inc..
[670789]
The customer reported that the frayed inner green wiring of the retractile cable of the mts centrifuge was exposed. The customer indicated that the issue was discovered during routine yearly maintenance. An exposed or broken wire may have the potential for electrical shock or fire.
Patient Sequence No: 1, Text Type: D, B5
[7875680]
The customer was instructed by ocd customer technical services (cts) to discontinue the use of the instrument. The replacement retractile cable part number was provided to the customer. This customer has not logged any complaints against this instrument since this incident. Product labeling cautions the user of the risk of electric shock involved in servicing the instrument. Product labeling provides the user with the proper procedure to follow when repairs are necessary. The root cause for the damaged wire is unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056600-2007-00163 |
| MDR Report Key | 862321 |
| Report Source | 05,06 |
| Date Received | 2007-06-08 |
| Date of Report | 2007-06-08 |
| Date of Event | 2007-05-15 |
| Date Mfgr Received | 2007-05-15 |
| Device Manufacturer Date | 2000-05-01 |
| Date Added to Maude | 2008-02-11 |
| 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 | DAVID HAGEN, SITE MGR, QRC |
| Manufacturer Street | 1295 S.W. 29TH AVE. |
| Manufacturer City | POMPANO BEACH FL 33069 |
| Manufacturer Country | US |
| Manufacturer Postal | 33069 |
| Manufacturer Phone | 9546239528 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTS 24 PLACE CENTRIFUGE |
| Generic Name | CENTRIFUGE |
| Product Code | KSO |
| Date Received | 2007-06-08 |
| Model Number | NA |
| Catalog Number | MTS515060 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 961212 |
| Manufacturer | MICRO TYPING SYSTEMS, INC. |
| Manufacturer Address | 1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-08 |