FDA Adverse Event Malfunction Summary report: N

HAMILTON MEDICAL AG

MDR report key: 18131326 · Received November 14, 2023

Report

Report Number: 3001421318-2023-15186
Event Type: Malfunction
Date Received: November 14, 2023
Date of Event: April 4, 2022
Report Date: November 8, 2023
Manufacturer: HAMILTON MEDICAL AG
Product Code: CBK
UDI-DI: 00730002856789
PMA / PMN Number: K181216
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE COMPLAINT HAS BEEN REOPENED AND REVIEWED ACCORDING TO FDA FORM 483 INSPECTIONAL OBSERVATION EMS #2, EOBS2 FROM THE FDA INSPECTION CONDUCTED BETWEEN JULY 17 TO JULY 21, 2022 AT THE EMS AND BONADUZ SITES. A DETAILED INVESTIGATION WAS PERFORMED BY AN EXPERT FROM THE TECHNICAL SERVICE: SINCE THE COMPLAINT IN QUESTION WAS SUBMITTED TO HAMILTON MEDICAL AG ALMOST 2 YEARS AGO, NO ATTEMPTS WILL BE PERFORMED TO OBTAIN ADDITIONAL INFORMATION. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT SIMILAR TO THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. WITH THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS AT THE TIME OF THE EVENT WHILE THE VENTILATOR WAS PREPARED FOR TREATMENT. THE ROOT CAUSE OF THE COMPLAINT WAS A FAILING NEBULIZER VALVE. IN CONSEQUENCE THE CORRECTION REPLACEMENT OF NEBULIZER VALVE MSP 161367 WAS CONDUCTED AND RESOLVED THE ISSUE. THERE WAS NO PATIENT OR USER HARM.

Description of Event or Problem · 0

TF 233006.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1916563	HAMILTON MEDICAL AG	HAMILTON-T1	CBK	HAMILTON MEDICAL AG	HAMILTON-T1		00730002856789

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown