MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1996-10-30 for PROPAQ CORDLESS 900-0093-00 manufactured by Protocol Systems, Inc..
[32985]
The mfr was telephoned on 10/2/96 by a user facility and informed that one pt had been mis-medicated as the result of a user error of one of the devices made by mfr. User facility reported that no pt injury resulted from the mis-medication. According to the usaer facility, a staff member applied a telemetry transmitter to a pt and failed to follow procedure to verify the correct frequency and id number according to device labeling. This error resulted in one pt's ecg data becoming temporarily confused with that of another nearby pt. The error was corrected by the user facility staff. Frequency of event statement: this is the first instance of a customer complaint of this kind reported to mfr. Severity of event statement: mfr is unaware of any rating or classification scale in which to rank or quantify the severity of a user error event of this kind.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3023750-1996-00003 |
| MDR Report Key | 47077 |
| Report Source | 06 |
| Date Received | 1996-10-30 |
| Date of Report | 1996-10-29 |
| Date of Event | 1996-10-01 |
| Date Mfgr Received | 1996-10-02 |
| Date Added to Maude | 1996-11-08 |
| 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 | 3 |
| 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 | 1996-10-30 |
| Model Number | NA |
| Catalog Number | 900-0093-00 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 47880 |
| 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 | 1996-10-30 |