MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-08-15 for SENSORMEDICS 41 SOMMONSTAR Z4 16618 manufactured by Cardinal Health 207, Inc..
[18241127]
The following description of the event was documented by a cardinal health tech support specialist in response to a phone conversation with a user facility representative. "claims that this cable actually shocked a technologist when he grabbed it; sees broken wires -states he knows electrical current is going through -wants all of his replaced immediately -says we sent him a replacement for one with artifact under order and this replacement is working better, and he can clearly see a better design now - is requesting replacement of all 5. I have done so on order number". The following additional information concerning the event was copied from a fax received from the user facility on 08/11/2008, in response to a letter sent by cardinal health seeking additional information. "the cable had pulled away from the multi-pin connector, exposing bare ground sheath. The technician claimed he felt a shock most likely esd from the wall to wall carpet. No current carried in this wire. "
Patient Sequence No: 1, Text Type: D, B5
[18358754]
The following information concerning the evaluation performed by the user facility was derived from a fax from the user facility's response to a letter sent by cardinal health seeking additional information. The user facility feels that the shock felt by their technician was most likely related to esd from the wall to wall carpet because there is no current running through the ground sheath. The report of frayed cable is a know event and no investigation will be performed. An investigation has already been performed for a similar complaint and another investigation is not necessary. The corrective or preventive measures for this issue reside in engineering change order.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2008-00068 |
| MDR Report Key | 1122358 |
| Report Source | 06 |
| Date Received | 2008-08-15 |
| Date of Report | 2008-08-15 |
| Date of Event | 2008-07-18 |
| Date Facility Aware | 2008-07-17 |
| Date Mfgr Received | 2008-07-18 |
| Device Manufacturer Date | 2008-03-21 |
| Date Added to Maude | 2009-02-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANTONIO CERVERA |
| Manufacturer Street | 1100 BIRD CENTER DR. |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal | 92262 |
| Manufacturer Phone | 7607787307 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSORMEDICS |
| Generic Name | SLEEP ANALYSIS SYSTEM |
| Product Code | BZC |
| Date Received | 2008-08-15 |
| Model Number | 41 SOMMONSTAR Z4 |
| Catalog Number | 16618 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 207, INC. |
| Manufacturer Address | 1100 BIRD CENTER DR. PALM SPRINGS CA 92262 US 92262 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-08-15 |