MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for MULTIPARAMETER PHYSIOLOGIC MONITOR MODULE E-PRESTN-00 manufactured by Ge Healthcare Products.
[91514691]
Patient Sequence No: 1, Text Type: N, H10
[91514692]
The blood pressure clip on the e-prestin module breaks off. No problem with the other vital clips. When the blood pressure cable is plugged in, the connection is loose and eventually breaks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7013685 |
| MDR Report Key | 7013685 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-06-14 |
| Report Date | 2017-09-28 |
| Date Reported to FDA | 2017-09-28 |
| Date Reported to Mfgr | 2017-09-28 |
| Date Added to Maude | 2017-11-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIPARAMETER PHYSIOLOGIC MONITOR MODULE |
| Generic Name | VITAL MODULE |
| Product Code | BZK |
| Date Received | 2017-11-09 |
| Model Number | E-PRESTN-00 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE PRODUCTS |
| Manufacturer Address | EILEEN FICK 3000 N GRANDVIEW BLVD. W-440 WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-09 |