MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-30 for 5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M M1668A manufactured by Philips Medical Systems.
[61452066]
A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[61452067]
The customer reported that a healthy woman was being monitored while under anesthesia and the device reported an asystole alarm. Cpr was started before an assessment of the patient's vital signs was made. It was reported that blood pressure and respiration were being monitored at the same time as rcg. It was confirmed that there was no patient injury as a result of the treatment that was initiated.
Patient Sequence No: 1, Text Type: D, B5
[74371585]
Patient Sequence No: 1, Text Type: N, H10
[74371586]
The customer reported a healthy woman was being monitored while under anesthesia and the device reported an asystole alarm. Cpr was started before an assessment of the patient's vital signs were made. It was reported that blood pressure and respirations were being monitored at the same time. Unnecessary emergent care was provided, that could have caused an injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610816-2016-00308 |
| MDR Report Key | 6135899 |
| Date Received | 2016-11-30 |
| Date of Report | 2016-11-09 |
| Date Mfgr Received | 2016-11-09 |
| Date Added to Maude | 2016-11-30 |
| 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 | MRS. WENDY CHADBOURNE |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M |
| Generic Name | ECG TRUNK CABLE |
| Product Code | DSA |
| Date Received | 2016-11-30 |
| Model Number | M1668A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-30 |