MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-31 for HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION 99400-000409 manufactured by Physio-control, Inc. - 3015876.
[134712773]
(b)(4). The biomedical engineer evaluated their device and was able to duplicate the reported issue. The biomed determined the cause of the reported issue was due to a failure of the internal paddles discharge control. The biomed replaced the internal paddles and after observing proper device operation through functional and performance testing, the device was returned to use. The device was not returned to physio-control for evaluation. The cause of the reported issue could not be determined. Device not evaluated by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[134712774]
The customer, a biomedical engineer, contacted physio-control to report that during patient use, their device would not recognize the internal paddles when connected. The device prompted to "connect cable" even though the cable was connected. The customer advised physio they connected the internal paddles to a second device with the same result. This issue is patient related; however there was no adverse patient outcome reported. No further details were provided by the customer. Physio-control contacted the customer in order to obtain additional information about both the patient and the event, however, the customer advised that no further details are available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0003015876-2019-00176 |
| MDR Report Key | 8295060 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-01-23 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2002-12-17 |
| Date Added to Maude | 2019-01-31 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MEG MARSEGLIA |
| Manufacturer Street | 11811 WILLOWS ROAD NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4258674000 |
| Manufacturer G1 | PHYSIO-CONTROL, INC. - 3015876 |
| Manufacturer Street | 11811 WILLOWS ROAD NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANDLES & CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION |
| Generic Name | INTERNAL DEFIBRILLATION CABLES |
| Product Code | LDD |
| Date Received | 2019-01-31 |
| Catalog Number | 99400-000409 |
| Lot Number | 09-2003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHYSIO-CONTROL, INC. - 3015876 |
| Manufacturer Address | 11811 WILLOWS ROAD NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-31 |