MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-25 for PKG; STANDARD CART W/ ISOLATION TRANSFORMER 0240099011 manufactured by Stryker Endoscopy-san Jose.
[90781674]
The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Additional information will be provided once the investigation has been completed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90781675]
It was reported that smoke appeared at the power cord of the medical cart.
Patient Sequence No: 1, Text Type: D, B5
[115021846]
Gtin: (b)(4). The device manufacture date is not known. Alleged failure: smoke came from power cord. Probable root cause: isolation transformer malfunctions, power strip malfunctions, circuit overload, current inrush, use error. The product was not returned for investigation therefore the reported failure mode was not confirmed. The reported failure mode will be monitored for future reoccurrence.
Patient Sequence No: 1, Text Type: N, H10
[115021847]
It was reported that smoke appeared at the power cord of the medical cart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936485-2017-00999 |
| MDR Report Key | 6978584 |
| Date Received | 2017-10-25 |
| Date of Report | 2018-04-09 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2017-09-27 |
| Date Added to Maude | 2017-10-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ASHLEY LOWER |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Street | 5900 OPTICAL COURT |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PKG; STANDARD CART W/ ISOLATION TRANSFORMER |
| Generic Name | CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) |
| Product Code | BZN |
| Date Received | 2017-10-25 |
| Catalog Number | 0240099011 |
| Lot Number | 080926AM027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY-SAN JOSE |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-25 |