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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DMS HOLDINGS/BRIGGS MEDICAL SERVICE CO. MEDIC KIT 5 MABIS MEDIC KIT 5

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DMS HOLDINGS/BRIGGS MEDICAL SERVICE CO. MEDIC KIT 5 MABIS MEDIC KIT 5 Back to Search Results
Model Number MEDIC KIT 5
Device Problems Air Leak (1008); Defective Device (2588); Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Type  Injury  
Event Description
Medic kit 5 (blood pressure) including mabis branded "caliber" sphygmomanometer, threaded connectors, and reusable blood pressure is unusable due to air leaks at female threaded connector of sphygmomanometer and male threaded connectors of cuff tubing. This was detected during routine pre-use testing; there was no pt involvement with the device failure six kits were received, all were found to be defective. The "caliber" model sphygmomanometer was an unannounced product substitution in the medic kit 5 for the previous and functional "signature" model sphygmomanometer. The threaded screw connectors in the kits with "caliber" sphygmomanometer were also found to leak with both the "signature" and "caliber" branded sphygmomanometer. To a casual or normal observer, the failing threaded connectors appear the same as the functional connectors. Under close examination there are differences in the thread pitch and count of the male connector, and the knurled barrel has a coarser knurled barrel. The air leak that renders the "caliber" medic kit 5 unusable appears to be due to a mismatch between the threaded connectors.
 
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Brand NameMEDIC KIT 5
Type of DeviceMABIS MEDIC KIT 5
Manufacturer (Section D)
DMS HOLDINGS/BRIGGS MEDICAL SERVICE CO.
waukegan IL 60085
MDR Report Key5360964
MDR Text Key35798723
Report NumberMW5059246
Device Sequence Number1
Product Code DXN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/07/2016
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Date FDA Received01/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMEDIC KIT 5
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/07/2016 Patient Sequence Number: 1
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