FDA Adverse Event
Malfunction
Summary report: N
SERVO-I
MDR report key: 2894343
·
Received December 21, 2012
Report
- Report Number
- 8010042-2012-00152
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 7, 2012
- Report Date
- November 26, 2012
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K062793
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EXPIRATORY CHANNEL PRINTED CIRCUIT BOARD, PC1784, WAS REPLACED DURING TROUBLESHOOTING AT THE HOSPITAL. THE REPLACED PC1784 HAS BEEN REQUESTED FOR INVESTIGATION BUT NOT YET RECEIVED. A FOLLOW-UP MDR WILL BE SENT WHEN INVESTIGATION IS COMPLETED. REFERENCE EXEMPTION #: (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PT TRANSPORT FROM ANOTHER HOSPITAL, THE VENTILATOR DISPLAYED AN IRREGULAR PEEP VALUE. THE PT WAS BAGGED FOR THE REST OF THE TRANSPORT. THERE WAS NO PT INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERVO-I | CBK | MAQUET CRITICAL CARE AB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |