N
Patient 1
MAUDE MDR 5689716
- MDR report key
- 5689716
- Report number
- 1419185-2016-00016
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-07-02
- Date received
- 2016-05-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS JESSICA BARRILE
- Address
- 1111 LAKESIDE DR GURNEE IL 60031 US
- Phone
- 847-847-8478
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CARE-E-VAC 3 | PORTABLE SUCTION DEVICE | OHIO MEDICAL | BTA | 758000 | 758000 | CEB071055 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-05-31 | 0 |
Event Narratives#
D
Patient 1
A USER FACILITY CALLED ON (B)(6) 2015 AND REQUESTED RETURN OF DEVICE BUT DID NOT SPECIFY THE PROBLEM. THERE WAS NO PATIENT INVOLVEMENT, AND THE INCIDENT DID NOT RESULT IN A DELAY OF TREATMENT. THE DEVICE WAS EVALUATED ON 07/02/2015 AND IT WAS NOTED THAT THE DEVICE HAD A BATTERY THAT WOULD NOT HOLD A CHARGE. OUR RISK DOCUMENT CLASSIFIES THE SEVERITY OF A DAMAGED DIAPHRAGM AS "POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE". WE ARE OBTAINING FURTHER CLINICAL EVALUATION OF THE RISK OF THIS FAILURE AND WILL PROVIDE FOLLOW UP TO THIS REPORT ONCE OBTAINED.
N
Patient 1
CLINICAL ASSESSMENT OF THE FAILURE MODE "DEAD BATTERY" HAS BEEN OBTAINED AND IT HAS BEEN DETERMINED THAT THIS OCCURENCE DOES NOT REPRESENT A REPORTABLE MALFUNCTION DUE TO NO EVIDENCE EXISTING TO REASONABLY SUGGEST THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR.
D
Patient 1
CLINICAL ASSESSMENT OF THE FAILURE MODE "DEAD BATTERY" HAS BEEN OBTAINED AND IT HAS BEEN DETERMINED THAT THIS OCCURENCE DOES NOT REPRESENT A REPORTABLE MALFUNCTION DUE TO NO EVIDENCE EXISTING TO REASONABLY SUGGEST THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR.
N
Patient 1
THIS REPORT IS A CORRECTION TO ORIGINAL REPORT SUBMITTED ON 01/29/2016: A USER FACILITY CALLED ON 06/02/2015 AND REQUESTED RETURN OF DEVICE BUT DID NOT SPECIFY THE PROBLEM. THERE WAS NO PATIENT INVOLVEMENT, AND THE INCIDENT DID NOT RESULT IN A DELAY OF TREATMENT. THE DEVICE WAS EVALUATED ON 07/02/2015 AND IT WAS NOTED THAT THE DEVICE HAD A BATTERY THAT WOULD NOT HOLD A CHARGE. INITIAL REVIEW OF THE COMPLAINT DEEMED THE INCIDENT AS NOT REPORTABLE BECAUSE THE FAILURE MODE WAS NOT CONSIDERED TO BE LIKELY TO CAUSE A SERIOUS INJURY OR DEATH SHOULD IT RECUR. AN EXTERNAL REVIEW OF THE COMPLAINT AND THE RISK MANAGEMENT DOCUMENTATION IDENTIFIED THIS COMPLAINT AS REPORTABLE BASED ON OUR RISK ASSESSMENT WHICH CLASSIFIES THE SEVERITY OF "DEAD BATTERY" AS "COMPLETE LOSS OF PERFORMANCE, MAY RESULT IN PERMANENT IMPAIRMENT OR SERIOUS INJURY OR DEATH." WE ARE OBTAINING FURTHER CLINICAL ASSESSMENT OF THE RISK OF THIS FAILURE MODE AS WELL AS EVALUATING THE RISK MANAGEMENT DOCUMENTATION AND WILL PROVIDE FOLLOW UP TO THIS REPORT ONCE THE ASSESSMENT IS COMPLETED.
D
Patient 1
THIS REPORT IS A CORRECTION TO ORIGINAL REPORT SUBMITTED ON 01/29/2016: A USER FACILITY CALLED ON 06/02/2015 AND REQUESTED RETURN OF DEVICE BUT DID NOT SPECIFY THE PROBLEM. THERE WAS NO PATIENT INVOLVEMENT, AND THE INCIDENT DID NOT RESULT IN A DELAY OF TREATMENT. THE DEVICE WAS EVALUATED ON 07/02/2015 AND IT WAS NOTED THAT THE DEVICE HAD A BATTERY THAT WOULD NOT HOLD A CHARGE. INITIAL REVIEW OF THE COMPLAINT DEEMED THE INCIDENT AS NOT REPORTABLE BECAUSE THE FAILURE MODE WAS NOT CONSIDERED TO BE LIKELY TO CAUSE A SERIOUS INJURY OR DEATH SHOULD IT RECUR. AN EXTERNAL REVIEW OF THE COMPLAINT AND THE RISK MANAGEMENT DOCUMENTATION IDENTIFIED THIS COMPLAINT AS REPORTABLE BASED ON OUR RISK ASSESSMENT WHICH CLASSIFIES THE SEVERITY OF "DEAD BATTERY" AS "COMPLETE LOSS OF PERFORMANCE, MAY RESULT IN PERMANENT IMPAIRMENT OR SERIOUS INJURY OR DEATH." WE ARE OBTAINING FURTHER CLINICAL ASSESSMENT OF THE RISK OF THIS FAILURE MODE AS WELL AS EVALUATING THE RISK MANAGEMENT DOCUMENTATION AND WILL PROVIDE FOLLOW UP TO THIS REPORT ONCE THE ASSESSMENT IS COMPLETED.