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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS SARL MEDSTREAM CONTROL UNIT

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MEDOS SARL MEDSTREAM CONTROL UNIT Back to Search Results
Catalog Number 914205
Device Problem Application Program Problem (2880)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturer¿s ref. No. : (b)(4). Information regarding patient weight, race, ethnicity, and medical history were not provided. The device is available to be returned for evaluation and testing. However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation. If the device returns, a device investigation will be performed. A review of manufacturing documentation associated with this lot (ckcdt2) from serial #(b)(4) presented no issues during the manufacturing or inspection processes related to the reported complaint. There were no non-conformance's related to device manufacture or inspection. The product conformed to specifications when it was released. Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission. The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report. Additional information will be submitted within 30 days of receipt.
 
Event Description
The healthcare professional reported that the medstream control unit (914205 / serial#: (b)(4) / lot# cdcdt2) was defective; the control unit suspends the programming process. It was reported that the device was able to communicate with the medstream pump and likely that the issue was related to the battery as the device was loaded regularly. The programming was correct but then drops out. There was no disruption of the baclofen treatment as the sales representative had another control unit available and this unit did not have any programming limitation. There was no report of any patient injury related to the reported event with the control unit.
 
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Brand NameMEDSTREAM CONTROL UNIT
Type of DeviceMEDSTREAM
Manufacturer (Section D)
MEDOS SARL
rue girardet 29
le locle jura CH-24 00
SZ CH-2400
Manufacturer (Section G)
MEDOS SARL
rue girardet 29
le locle jura CH-24 00
SZ CH-2400
Manufacturer Contact
gabriel alfageme
31 technology drive
irvine, CA 92618
949789-868
MDR Report Key8624505
MDR Text Key146541595
Report Number8031062-2019-00514
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P890055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/29/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2009
Device Catalogue Number914205
Device Lot NumberCKCDT2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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