MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-06-16 for PROPAQ CORDLESS 900-0093-00 manufactured by Protocol Systems, Inc..
[20431555]
Two pt's ecg telemetry signals were monitored incorrectly for a period of approximately three hours. The problem was discovered when a nurse removed the ecg leads from one pt but the pt monitor continued to display a rhythm. No pt injury resulted. Investigation showed that when an ecg telemetry transmitter was applied to one pt, a hosp staff member failed to follow procedure to verfity the correct frequency and transmitter id number according to device labeling. This error resulted in the pt's ecg data becoming temporarily confused with that of another nearby pt. The error was detected and corrected by the user facility staff. Frequency of event statement: this is the second instance of a customer complaint of this kind reported to the mfr during the last twelve months. Severity of event statement: manufacture is unaware of any rating or classification scale in which to rank or quantify the severity of a user error of this kind.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3023750-1997-00001 |
| MDR Report Key | 99835 |
| Report Source | 06 |
| Date Received | 1997-06-16 |
| Date of Report | 1997-06-16 |
| Date of Event | 1997-05-01 |
| Date Mfgr Received | 1997-05-01 |
| Date Added to Maude | 1997-06-25 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROPAQ CORDLESS |
| Generic Name | TELEMETRY TRANSMITTER |
| Product Code | GYE |
| Date Received | 1997-06-16 |
| Model Number | NA |
| Catalog Number | 900-0093-00 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 98358 |
| Manufacturer | PROTOCOL SYSTEMS, INC. |
| Manufacturer Address | 8500 S.W. CREEKSIDE PLACE BEAVERTON OR 970087107 US |
| Baseline Brand Name | PROPAQ CORDLESS |
| Baseline Generic Name | TELEMETRY |
| Baseline Model No | NA |
| Baseline Catalog No | 900-0093-00 |
| Baseline ID | NA |
| Baseline Device Family | CORDLESS |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K934711 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-06-16 |