FDA Adverse Event Malfunction Summary report: N

HAMILTON MEDICAL AG

MDR report key: 18561259 · Received January 23, 2024

Report

Report Number: 3001421318-2023-26430
Event Type: Malfunction
Date Received: January 23, 2024
Date of Event: October 1, 2020
Report Date: January 22, 2024
Manufacturer: HAMILTON MEDICAL AG
Product Code: CBK
UDI-DI: 00730002856789
PMA / PMN Number: K181216
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
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: THIS ISSUE IS DEEMED A REPORTABLE EVENT SINCE THE MALFUNCTION LED TO AN INOPERABLE DEVICE. THE ROOT CAUSE IS A MALFUNCTION OF THE ESM BOARD. WITHIN THIS INVESTIGATION IT HAS BEEN CONFIRMED THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS WHEN THE VENTILATOR WAS SWITCHED ON. THERE WAS NO PATIENT OR USER HARM. THE ALLEGATION IN THIS COMPLAINT WAS CONFIRMED TO BE A COMPLAINT. NO FURTHER INVESTIGATION OR CORRECTION WILL BE PERFORMED EXCEPT THOSE MENTIONED ABOVE. IN FUTURE HAMILTON MEDICAL AG WILL REPORT AN EVENT LIKE THIS ISSUE AS IT WILL BE DEEMED A REPORTABLE EVENT.

Description of Event or Problem · 0

MACHINE IS SHOWING TECHNICAL EVENT (246010 ; 233006 ; 233004 ; 233003; 233001; 231022; 285001; 285002) MACHINE IS ALSO SHOWING FAN FAILED & ERROR READ HARDWARE COMPONENT EEPROM. VENTILATOR IS ALSO NOT SWITCHING ON IN AC POWER

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
797099	HAMILTON MEDICAL AG	HAMILTON-C1	CBK	HAMILTON MEDICAL AG	HAMILTON-C1		00730002856789

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown