MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for PEDIATRIC EKG TELEMETRY MONITOR manufactured by Ge Healthcare.
[35327067]
Patient Sequence No: 1, Text Type: N, H10
[35327068]
The plastic sheath covering the metal prongs became dislodged when changing the patient ekg leads on the pediatric adapter being used for patient monitoring. On the next day, the patient was receiving a bath and changing ekg leads. The pediatric ekg adapter came apart during this time exposing metal prongs. The department representative indicated that their unit uses ge pediatric adapters to fit their unit's smaller patients. Clorox wipes are used to clean the adapters. This is not a recurring problem, although it happens every so often.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5353093 |
| MDR Report Key | 5353093 |
| Date Received | 2016-01-08 |
| Date of Report | 2015-12-10 |
| Date of Event | 2015-03-19 |
| Report Date | 2015-12-10 |
| Date Reported to FDA | 2015-12-10 |
| Date Reported to Mfgr | 2015-12-10 |
| Date Added to Maude | 2016-01-08 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDIATRIC EKG TELEMETRY MONITOR |
| Generic Name | PEDIATRIC EKG ADAPTER |
| Product Code | DRW |
| Date Received | 2016-01-08 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 9900 W. INNOVATION DRIVE MAIL STOP RP-2138 WAUWATOSA WI 53226 US 53226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-08 |