NA
Report
- Report Number
- 3020115-2015-00001
- Date Received
- August 31, 2015
- Report Date
- August 31, 2015
- Manufacturer
- PARKS MEDICAL ELECTRONICS, INC.
- Product Code
- IYN
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
REFERENCE ORIGINAL SUBMISSION (08/31/2015) AND FOLLOW-UP #1 (12-11-2015) FOR MORE BACKGROUND.
PMEI INITIATED A CAPA (CAPA 15-(B)(4)) ON 08/31/2015. REMEDIAL ACTION AS PART OF CAPPA (B)(4) WAS THE ISSUANCE OF A LETTER POSTED TO THE PMEI WEB SITE INDICATING THAT PMEI'S DEVICES ARE CLASS II, NON-INVASIVE DEVICES NOT INTENDED FOR SUBCUTANEOUS USE - THIS WAS IMPLEMENTED ON 9/3/2015. INVESTIGATION ASSOCIATED WITH THE CAPA REVOLVED AROUND A REVIEW OF ALL 25 USER'S MANUALS FOR ALL OF PMEI'S DEVICES, AS WELL AS A REVIEW OF ITS ONLINE ADVERTISING LITERATURE. (B)(4) WAS OPENED AS PART OF THE CAPA TO IMPLEMENT REVISIONS TO ALL OF PMEI'S USER MANUALS AND ADVERTISING LITERATURE. AMONG THE CHANGES IMPLEMENTED: ADDING A FOOTER TO EVERY PAGE OF EVERY MANUAL AND ADVERTISING BROCHURE THAT PMEI DEVICES ARE CLASS II AND NOT INTENDED FOR SUBCUTANEOUS USE. CAPTIONS WERE ADDED TO ALL ILLUSTRATIONS INDICATING THAT THEY WERE FOR ILLUSTRATIVE PURPOSES ONLY AND THAT THE DEVICE IS NOT INTENDED FOR SUBCUTANEOUS USE. CONTRAINDICATION LANGUAGE WAS STRENGTHENED AND STANDARDIZED IN EACH MANUAL, AND VAGUE LANGUAGE THA COULD POTENTIALLY CONFUSE A POTENTIAL USER AS THO THE DEVICE'S INTENDED USE WAS ELIMINATED. PMEI IS CURRENTLY WORKING WITH (B)(6) TO PUBLISH THESE REVISED MANUAL TO THE VA ELECTRONIC DOCUMENT SYSTEM, ONESOURCE. THE CAPA WILL BE CLOSED ONCE PMEI HAS CONFIRMED THAT (B)(6) HAS PUBLISHED THE REVISED MANUALS.
THE SOURCE OF THE COMPLAINT INDICATES THAT PMEI'S LABELING IS VAGUE AS TO THE INTENDED USE OF ITS DEVICES AS WELL AS CONTRAINDICATIONS. THIS WILL BE THE SUBJECT OF OUR CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION, IN ADDITION TO WHETHER ANY PMEI DEVICES HAVE BEEN INVOLVED IN ADVERSE EVENTS AS A RESULT OF THIS REPORTED MISUSE. TO DATE (B)(6) HAS SUPPLIED US WITH NO SPECIFIC INFORMATION REGARDING ANY ADVERSE EVENTS AT THEIR FACILITIES CONNECTED WITH THE MISUSE OF PMEI DEVICES - THIS WILL BE PURSUED IN THE DAYS TO COME - AND RESULTS WILL BE PROVIDED IN SUPPLEMENTAL REPORTS.
THIS IS A SUPPLEMENTAL REPORT (FOLLOW-UP #2). PLEASE REFER TO INITIAL MDR FOR DESCRIPTION. THAT ORIGINAL REPORT WAS SENT ON 08/31/2015. ON (B)(6) 2015, PMEI WAS NOTIFIED BY THE VA'S DOCUMENTATION DATABASE (ONESOURCE) OPERATORS THAT ALL PMEI MANUALS HAD BEEN UPLOADED AS REVISED. THESE REVISIONS WERE COMPLETED PER PMEI CO 15-007 VIA PMEI CAPA (B)(4). ALL 25 PMEI USER'S MANUALS WERE REVISED TO STRENGTHEN AND STANDARDIZE THEIR CONTRAINDICATION LANGUAGE. THIS INCLUDES ADDING A FOOTER TO EVERY PAGE OF EVERY MANUAL INDICATING THAT PMEI EQUIPMENT IS CLASS II, NON-INVASIVE EQUIPMENT NOT INTENDED FOR SUBCUTANEOUS USE AS WELL AS CLARIFYING CAPTIONS FOR ALL ILLUSTRATIONS. PMEI ADDITIONALLY PER CO 15-007 REVISED ALL 14 PMEI ONLINE ADVERTISING BROCHURES TO STRENGTHEN AND STANDARDIZE THEIR CONTRAINDICATION LANGUAGE. THIS INCLUDES ADDING A FOOTER TO EVERY PAGE OF EVERY BROCHURE INDICATING THAT PMEI EQUIPMENT IS CLASS II, NON-INVASIVE EQUIPMENT NOT INTENDED FOR SUBCUTANEOUS USE. PMEI CLOSED CO 15-007 ON (B)(6) 2015. PMEI CLOSED CAPA (B)(4) ON (B)(6) 2016. THE OIG INVESTIGATION REMAINS OPEN, HOWEVER PMEI HAS NOT HEARD FROM THE OIG SINCE (B)(6) 2015. TO DATE PMEI HAS NOT BEEN MADE AWARE OF A SPECIFIC INSTANCE OF ITS DEVICES BEING USED IN A CONTRAINDICATED FASHION NOR ANY ADVERSE EVENTS AS A RESULT OF SUCH PURPORTED MIS-USE. PMEI CONSIDERS THIS MATTER "CLOSED" AS OF (B)(6) 2016. IN THE EVENT THE OIG REPORTS BACK TO PMEI ANOTHER SUPPLEMENTAL WILL BE FILED TO DETAIL ANY APPLICABLE FINDINGS.
THIS IS A SUPPLEMENTAL REPORT (FOLLOW-UP #1). PLEASE REFER TO INITIAL MDR FOR DESCRIPTION. THAT ORIGINAL REPORT WAS SENT ON 08/31/2015. ON 09/08/2015, PMEI WAS NOTIFIED BY (B)(6) THAT THEY HAD ACCEPTED THIS CASE FOR INVESTIGATION. FOLLOWING IS THE TEXT FROM (B)(6) NOTIFICATION: "(B)(6) HAS OPENED A CASE BASED ON A REVIEW OF THE INFORMATION YOU REPORTED TO OUR OFFICE. THE CASE NUMBER ASSIGNED IS (B)(4). NOW THAT WE HAVE OPENED A CASE, OUR OFFICE WILL REVIEW THE ISSUES YOU REPORTED, OR ASK AN IMPARTIAL VA OFFICIAL TO CONDUCT THE REVIEW. IF WE ASK ANOTHER (B)(6) OFFICE TO CONDUCT THE REVIEW, WE WILL ENSURE THE REVIEWER FULLY EXAMINES THE ISSUES BEFORE CLOSING THE CASE. PLEASE BE ADVISED THAT ONCE A CASE IS OPENED, WE CANNOT DISCUSS ITS PROGRESS. WE WILL CONTACT YOU AGAIN ONLY IF WE NEED MORE INFORMATION. OTHERWISE, WE WILL NOTIFY YOU WHEN THE CASE IS CLOSED."PMEI FELLS IT IS APPROPRIATE TO FILE A SUPPLEMENTAL AT THIS TIME BECAUSE SO MUCH TIME HAS PASSED SINCE THE ORIGINAL MDR WAS ISSUED. PMEI HAS NOT HEARD BACK FROM OIG SINCE 9/8/2015. NOR HAS PMEI BEEN OTHERWISE AWARE OF ANY SPECIFIC INSTANCE OF ITS DEVICES BEING USED IN CONTRAINDICATED FASHION OR ANY ADVERSE EVENTS AS A RESULT OF SUCH MIS\-USE. PMEI WILL FILE ANOTHER SUPPLEMENTAL UPON THE CLOSURE OF OIG'S INVESTIGATION RELAYING THE RESULTS.
PER ONE OF OUR CUSTOMERS ((B)(6)): UNSPECIFIED (B)(6) SURGEONS HAVE BEEN OR ARE USING OUR DOPPLERS (NUMBER OF DEVICES, DATES OF USE, ID#'S IF DEVICES AND PATIENT ID'S UNSPECIFIED) IN INVASIVE OPERATIONS (I.E. SUBCUTANEOUSLY). PMEI DEVICES ARE CLASS II DEVICES WHICH ARE NOT DESIGNED FOR THIS TYPE OF USE. USE OF PMEI DOPPLERS IN THIS CONTRAINDICATED FASHION COULD RESULT IN PATIENT INFECTION. AT PRESENT (8/31/15) PMEI HAS NO SPECIFIC INFORMATION AS TO THE FACILITIES INVOLVED, DEVICES INVOLVED, PATIENTS INVOLVED, DATES INVOLVED, ETC. HOWEVER IF THIS IS ACTUALLY OCCURRING THE USE OF OUR DEVICES IN THIS MANNER COULD POSSIBLY RESULT IN SERIOUS INJURY OR DEATH - THUS NECESSITATING THIS REPORT. (B)(6) HAS BEEN A CUSTOMER OF PMEI SINCE AT LEAST THE MID-1990'S. TO DATE (PENDING FURTHER INVESTIGATION) THERE HAVE BEEN NO COMPLAINTS ASSOCIATING THE USE OF PMEI DEVICES N THIS FASHION WITH ANY ACTUAL ADVERSE EVENT. FURTHER INVESTIGATION WILL DETERMINE THE EXTENT OF PMEI DEVICE INVOLVEMENT IN ANY REPORTABLE ADVERSE EVENTS OVER THE PAST 20 YEARS. THIS CONCERN HAS NOT BEEN RAISED BY ANY OF OUR OTHER CUSTOMERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576744 | NA | IYN | PARKS MEDICAL ELECTRONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |