MAUDE Adverse Event Report: OHIO MEDICAL CARE E VAC 3; PORTABLE SUCTION UNIT

Model Number 758000

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2015

Event Type  malfunction  

Event Description

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 (b)(6) 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.

Manufacturer Narrative

This is a follow up to corrected report submitted on (b)(6) 2016: 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.(b)(4).

Event Description

This is a follow up to corrected report submitted on (b)(6) 2016: 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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: CARE E VAC 3
• Type of Device: PORTABLE SUCTION UNIT
• 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 dr; gurnee, IL 60031 ; 8478556318
• MDR Report Key: 5689628
• MDR Text Key: 47299739
• Report Number: 1419185-2016-00015
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 758000
• Device Catalogue Number: 758000
• Device Lot Number: CEB071055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1