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

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.

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 8240385
• MDR Text Key: 132994743
• Report Number: 8010042-2019-00024
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• 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 Number: 6487800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1