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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OHIO MEDICAL CARE-E-VAC 3; PORTABLE SUCTION DEVICE
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OHIO MEDICAL CARE-E-VAC 3; PORTABLE SUCTION DEVICE Back to Search Results
Model Number 758000
Device Problems Battery Problem (2885); Charging Problem (2892)
Patient Problem No Patient Involvement (2645)
Event Date 03/01/2013
Event Type  malfunction  
Event Description
A user facility reported on 01/28/2013 that the unit would not hold a charge.There was no patient involvement, and the incident did not result in a delay of treatment.The device was evaluated on 03/01/2013 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.
 
Manufacturer Narrative
This is a follow up to a corrected report submitted on 2/23/2016: clinical assessment of the failure mode "battery will not hold a charge" has been obtained and it has been determined that this occurrence 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.
 
Event Description
This is a follow up to a corrected report submitted on 2/23/2016: clinical assessment of the failure mode "battery will not hold a charge" has been obtained and it has been determined that this occurrence 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.
 
Manufacturer Narrative
A user facility reported on (b)(6) 2013 that the unit would not hold a charge.There was no patient involvement, and the incident did not result in a delay of treatment.The device was evaluated on 03/01/2013 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.
 
Event Description
A user facility reported on (b)(6) 2013 that the unit would not hold a charge.There was no patient involvement, and the incident did not result in a delay of treatment.The device was evaluated on 03/01/2013 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.
 
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Brand Name
CARE-E-VAC 3
Type of Device
PORTABLE SUCTION DEVICE
Manufacturer (Section D)
OHIO MEDICAL
1111 lakeside dr
gurnee IL 60031
Manufacturer (Section G)
OHIO MEDICAL
1111 lakeside dr
gurnee IL 60031
Manufacturer Contact
jessica barrile
1111 lakeside
gurnee, IL 60031
8478556318
MDR Report Key5689838
MDR Text Key47317468
Report Number1419185-2016-00020
Device Sequence Number1
Product Code BTA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial,Followup,Followup
Report Date 02/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number758000
Device Catalogue Number758000
Device Lot NumberCEB101016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received01/28/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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