D
Patient 1
THE CUSTOMER PROVIDED ADDITIONAL INFORMATION REGARDING THE PATIENT EVENT: PATIENT WAS AN ELDERLY FEMALE WHO WEIGHED APPROXIMATELY 90 POUNDS.
MAUDE MDR 3687704
- MDR report key
- 3687704
- Report number
- 3015876-2014-00278
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-02-17
- Date received
- 2014-03-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JASON MARCH
- Phone
- 425-425-4258
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TRUECPR? | AID, CARDIOPULMONARY RESUSCITATION | PHYSIO-CONTROL, INC | LIX | TRUECPR? COACHING DEVICE | 3309630 | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-03-19 | 0 |
Event Narratives#
N
Patient 1
ADDITIONAL PATIENT INFORMATION WAS RECEIVED. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA.
N
Patient 1
PHYSIO-CONTROL PERFORMED AN EVALUATION ON THE DEVICE AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING.
D
Patient 1
THE CUSTOMER REPORTED THAT DURING A PATIENT INCIDENT, THE CUSTOMER EXPERIENCED INACCURACIES IN THE FEEDBACK FROM THEIR TRUECPR COACHING DEVICE. DURING THE INCIDENT, THE CUSTOMER STATED THAT THE RECOIL OF THE CHEST WAS REDUCED AND WITH THAT, THE CUSTOMER EXPRESSED THE FEEDBACK WAS INACCURATE AND INEFFECTIVE. THERE WAS PATIENT USE ASSOCIATED HOWEVER, DETAILS AND THE OUTCOME OF THE PATIENT WAS NOT REPORTED.
N
Patient 1
(B)(4). PHYSIO-CONTROL HAS INVESTIGATED THE REPORTED ISSUE. PHYSIO HAS DETERMINED THAT THE LIKELY CAUSE OF THE REPORTED ISSUE IS DUE TO INACCURATE DEPTH MEASUREMENT DISPLAYED BY THE DEVICE AS A RESULT OF A COMBINATION OF FACTORS RELATING TO USER HAND PLACEMENT AND PATIENT ANATOMY. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.
N
Patient 1
PHYSIO-CONTROL HAS PERFORMED ADDITIONAL CLINICAL AND ENGINEERING ANALYSIS OF THE REPORTED COMPRESSION DEPTH FEEDBACK ACCURACY ISSUE, AND THROUGH THE COURSE OF THAT INVESTIGATION HAS DETERMINED THAT THE DEVICE IS OPERATING WITHIN ITS PRODUCT REQUIREMENTS AND SPECIFICATIONS. IT WAS ALSO DETERMINED THAT THE CURRENT PRODUCT DESIGN MEETS ESTABLISHED USER NEEDS AND ACHIEVES A COACHING BENEFIT TO THE USER FOR DELIVERY OF CARDIOPULMONARY RESUSCITATION (CPR) THERAPY. PHYSIO-CONTROL HAS INVESTIGATED THE REPORTED ISSUE OF INACCURATE DEPTH MEASUREMENT AND HAS VERIFIED THE ISSUE. PHYSIO HAS DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE IS THE RESULT OF A COMBINATION OF FACTORS RELATING TO USER HAND PLACEMENT AND PATIENT ANATOMY.