MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-10-14 for SENSORMEDICS 41 SOMNOSTAR Z4 16618 manufactured by Cardinal Health 207, Inc..
[926627]
[in 2008] "customer called stated that one of her night techs stated that she got shocked by our amp. She stated that the night tech stated it was from the cable. Told customer that i will have tech call her back. Customer understood and call detail given customer. [same day] "customer was called back to obtain more information on incident. Customer states that they had problem with getting cable connected correctly and stated that it is very difficult. She states that on friday night when incident occurred, she was shocked by jackbox cable, where it plugs into on headbox. Customer states that electric shock was felt on finger when attempting to connect the end that plugs in headbox. They swapped out cable from other bed to complete study for the night. Physician said it looked like a minor wound but was considered if equipment is safe, we will investigate equipment that is sent in and will replace their equipment". The following additional information concerning the event was copied from an e-mail received from the user facility on 10/10/2008, in response to a letter sent by cardinal health seeking additional information and a phone conversation with a user facility representative. "our night psg tech called to say that as she was attempting to insert the cable end into the head box at which point she experienced a shock. She felt that the shock came from the end plug of the cable. I went to the lab (the month prior) to personally look at the situation. The tech showed me the cable in question as well as her left index finger where she felt the shock. There appeared to be a pink looking area at the tip of the finger approximately. 25 centimeters in diameter she had no pain or blood. She refused any treatment including putting a band aid on it. Employee refused any treatment and did not appear in any distress except for the shock over the shock. Dr. [name removed] believes that the pink area on finger was caused somewhere else and not by the shock incident. "
Patient Sequence No: 1, Text Type: D, B5
[8241729]
Cardinal health issued a return goods authorization (rga) number to the user facility for the return of the alleged facility devices for evaluation. As of the date of this report, the alleged fault devices have not been received. The user facility was shipped a replacement headbox assembly, 50 pin cable assembly and sleep amp assembly to repair the device. The customer installed the replacement components and now the device is back in service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2008-00088 |
| MDR Report Key | 1199485 |
| Report Source | 06 |
| Date Received | 2008-10-14 |
| Date of Report | 2008-10-13 |
| Date of Event | 2008-09-12 |
| Date Facility Aware | 2008-09-12 |
| Date Mfgr Received | 2008-09-15 |
| Device Manufacturer Date | 2008-04-29 |
| Date Added to Maude | 2009-05-29 |
| 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 | 2008-10-14 |
| Model Number | 41 SOMNOSTAR Z4 |
| Catalog Number | 16618 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| 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 | 2008-10-14 |