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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-I; VENTILATOR, CONTINUOUS, FACILITY USE

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MAQUET CRITICAL CARE AB SERVO-I; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Catalog Number 6487800
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 01/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the user interface holder was damaged.There was no patient involvement.(b)(4).
 
Event Description
Importer ref.#: (b)(4).Manufacturer ref.#: 1902mcc0077.
 
Manufacturer Narrative
Our field service engineer replaced the broken user interface holder.The ventilator was returned to the customer and cleared for clinical use after passed functional and safety test per factory specifications.No part was returned and no picture of the broken holder was received.The user interface holder has most probably been exposed to a mechanical force greater than it¿s designed to sustain.The consequence of this kind of mechanical damage is that the panel user interface may get detached and in a worst case falls off the ventilator carrier.It is unknown under which conditions the reported user interface holder broke.The ventilator system was successfully tested for mechanical strength, with a peak acceleration of 15 g, pulse duration 6 ms, and total number of (b)(4) impacts.
 
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Brand Name
SERVO-I
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW 
MDR Report Key8240385
MDR Text Key132994743
Report Number8010042-2019-00024
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K123149
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6487800
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/07/2019
Initial Date FDA Received01/11/2019
Supplement Dates Manufacturer Received01/07/2019
Supplement Dates FDA Received09/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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