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

Model Number SERVO-I

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Information (3190)

Event Date 02/05/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator was faulty.Patient involvement is unknown.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

The received information is not specific enough to point to any particular fault.We haven't received any update, logs or service report.Despite several reminders the only information received regarding this complaint is the information stated in the complaint form, which is not enough to determine the root cause of the reported failure.Given this, we have not been able to confirm the problem nor can we identify any root cause.H3 other text : 4117.

Event Description

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
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 11377111
• MDR Text Key: 233448823
• Report Number: 8010042-2021-00487
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

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 Model Number: SERVO-I
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1