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 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the user interface holder was broken off.There was no patient involvement.(b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of maquet critical care ab (manufacturer).Ref.Exemption #:(b)(4).Getinge usa sales, llc (b)(4).Contact peron:(b)(4).The ventilator was investigated by our field service engineer (fse).The reported failure was confirmed and the user interface holder was replaced.The ventilator was returned to clinical use.The failure was confirmed with a photo provided the fse.The consequence of this kind of mechanical damage is that the user interface gets detached and, in a worst case scenario, falls off the ventilator carrier.Our conclusion into this matter is that the user interface has been exposed to a mechanical force greater than it is designed to sustain.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.

Event Description

Importer ref.#: (b)(4).Manufacturer ref.#: (b)(4).

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 8436433
• MDR Text Key: 139454456
• Report Number: 8010042-2019-00184
• 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: 05/13/2019

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: 03/13/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1