WELCH ALLYN, INC.
Report
- Report Number
- 2183461-2023-00027
- Event Type
- Malfunction
- Date Received
- December 15, 2023
- Date of Event
- November 28, 2023
- Report Date
- June 17, 2024
- Manufacturer
- WELCH ALLYN INC
- Product Code
- DPS
- UDI-DI
- 00817655022604
- PMA / PMN Number
- K191013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE IS A PRESCRIPTION DEVICE INTENDED FOR USE BY PHYSICIANS, OTHER LICENSED HEALTH CARE PRACTITIONERS, AND TRAINED PERSONNEL WHO ARE ACTING ON THE ORDERS OF A PHYSICIAN. WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE IS INTENDED FOR USE IN MEDICAL CLINICS, PHYSICIAN OFFICES AND HOSPITAL SETTINGS TO ACQUIRE, ANALYZE, DISPLAY, TRANSMIT AND PRINT CERTAIN PHYSIOLOGICAL SIGNALS IDENTIFIED BELOW AND PROVIDE THE DATA FOR CONSIDERATION BY A PHYSICIAN. WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE UTILIZES A SOFTWARE PLATFORM TO SUPPORT 12-LEAD DIAGNOSTIC RESTING ECG AND DIAGNOSTIC SPIROMETRY APPLICATIONS AND IS DESIGNED TO OPERATE WITHIN THE INHERENT CAPABILITIES OF AN OFF-THE-SHELF LAPTOP OR PC WINDOWS OPERATING SYSTEM. WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE ALSO PROVIDES FUNCTIONS RELATED TO PATIENT DATA MANAGEMENT INCLUDING COMMUNICATION WITH ELECTRONIC MEDICAL RECORDS SYSTEMS. WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE RESTING ECGS ARE INTENDED TO BE TAKEN WITH THE PATIENT IN THE SUPINE POSITION AND OFFER VERITAS¿ RESTING ECG ALGORITHM TO GENERATE MEASUREMENTS AND ADVISORY STATEMENTS FOR REVIEW AND INTERPRETATION BY THE PHYSICIAN. WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE IS NOT INTENDED TO BE USED AS A PHYSIOLOGICAL VITAL SIGNS MONITOR, NOT INTENDED TO BE USED IN A MOBILE MEDICAL ENVIRONMENT (E.G. AMBULANCE, HELICOPTER), IN MAGNETIC RESONANCE (MR) ENVIRONMENTS, IN OPERATING THEATERS, NOR IN CONJUNCTION WITH HIGH FREQUENCY SURGICAL EQUIPMENT. INDICATIONS FOR WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE RESTING ECG RANGE FROM ROUTINE SCREENING OF CARDIAC HEALTH IN THE PHYSICIAN OFFICE ENVIRONMENT TO DIRECTED DIAGNOSTIC DIFFERENTIATION IN A HOSPITAL CARDIOLOGY DEPARTMENT. WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE ECG IS INDICATED FOR PATIENTS OF ALL AGES. DURING REMOTE TROUBLESHOOTING BY TECHNICAL SERVICES, IT WAS CONSIDERED THAT THE PROBLEM MAY BE DUE TO AN UNKNOWN SOFTWARE CODING ISSUE. HOWEVER, THE CUSTOMER DID NOT RETURN THE DEVICE FOR INVESTIGATION SO A ROOT CAUSE OF THE REPORTED MALFUNCTION COULD NOT BE CONFIRMED. ALTHOUGH THERE WAS NO PATIENT HARM REPORTED IN THIS CASE, IF AN INCORRECT ASSOCIATION OF ECG RECORDS WITH WRONG PATIENT CHARTS WERE TO RECUR, IT COULD LEAD TO MISDIAGNOSIS AND/OR MISTREATMENT WHICH COULD ULTIMATELY LEAD TO PATIENT HARM, THEREFORE, HILLROM CONSIDERS THIS COMPLAINT REPORTABLE.
THIS SUPPLEMENTAL REPORT IS A CORRECTION TO THE PREVIOUSLY SUBMITTED MDR. FOLLOWING COMMUNICATION FROM THE FDA REGARDING INCORRECT/MISSING UDI NUMBERS, BAXTER REVIEWED THE SUBJECT MDR AND DETERMINED BRAND NAME, 510K, AND UDI CORRECTIONS WERE REQUIRED TO THIS MDR IN ALIGNMENT WITH THE GUDID. THE CUSTOMER WAS UNABLE TO PROVIDE THE SERIAL NUMBER DESPITE MULTIPLE ATTEMPTS, THEREFORE, THE SERIAL NUMBER AND MANUFACTURING DATE REMAIN UNKNOWN IN THE MDR.
THE CUSTOMER REPORTED A NUMBER OF CONFIGURATION ISSUES WITH THE WADCS INCLUDING THE PATIENT ID WAS INCORRECT. THERE WAS NO ASSOCIATED ADVERSE EVENT REPORTED AS A RESULT OF THIS INCIDENT.THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).
THE CUSTOMER REPORTED A NUMBER OF CONFIGURATION ISSUES WITH THE WADCS INCLUDING THE PATIENT ID WAS INCORRECT. THERE WAS NO ASSOCIATED ADVERSE EVENT REPORTED AS A RESULT OF THIS INCIDENT. THIS INCIDENT WAS CAPTURED UNDER BAXTER COMPLAINT REF # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2269340 | WELCH ALLYN, INC. | ELECTROCARDIOGRAPH | DPS | WELCH ALLYN INC | 901128 | 00817655022604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |