MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-15 for HEWLETT PACKARD 43100A manufactured by Hewlett Packard (now Own By Philips Medical System Inc).
[790955]
Pt coded. Upon initiation of cardiopulmonary resuscitative efforts, the defibrillator would not function. Another defibrillator had to be retrieved. Upon evaluation by biomedical services it was found that the plug and receptacle for the ecg leads had at some time (whether during this code or at some time in the past cannot be determined) been physically damaged, rendering the defibrillator nonfunctioning. It is not thought that the delay affected the eventual outcome. However, it is agreed that such a delay holds the potential for changing an outcome in a future occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 982820 |
| MDR Report Key | 982820 |
| Date Received | 2008-01-15 |
| Date of Event | 2008-01-03 |
| Date Facility Aware | 2008-01-03 |
| Report Date | 2008-01-14 |
| Date Reported to FDA | 2008-01-14 |
| Date Reported to Mfgr | 2008-01-14 |
| Date Added to Maude | 2008-01-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEWLETT PACKARD |
| Generic Name | DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 2008-01-15 |
| Model Number | 43100A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 952121 |
| Manufacturer | HEWLETT PACKARD (NOW OWN BY PHILIPS MEDICAL SYSTEM INC) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-15 |