MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD KV-5 (OE 220-240V 50/60HZ); KV-5 SUCTION PUMP AND ACCESSORIES

Model Number K7502135

Device Problems Degraded (1153); Suction Problem (2170); Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Description from customer reads "we have observed for several months that the filters for the kv5 suction pumps have significantly lost quality.The filters cannot be firmly inserted into the pumps, they slip out again, so that reliable suction performance is not given.In an emergency situation, lack of suction power can become a major problem.We have temporarily fixed them with plaster strips, but this cannot be a permanent solution.I would therefore kindly ask you to look into this matter and supply other filters if necessary.".

Manufacturer Narrative

Olympus will further investigate the case in order to assess the incident.

Manufacturer Narrative

Device / filters not returned to olympus keymed.No meaningful investigation possible, and therefore no root cause could be established.If any new information is received the case will be reviewed.

• Brand Name: KV-5 (OE 220-240V 50/60HZ)
• Type of Device: KV-5 SUCTION PUMP AND ACCESSORIES
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD; keymed house, stock road; southend on sea, essex SS25Q H; UK SS25QH
• Manufacturer (Section G): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD; keymed house, stock road; southend on sea, essex
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16310815
• MDR Text Key: 308977006
• Report Number: 9611174-2023-00009
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K7502135
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1