FDA Adverse Event
Malfunction
Summary report: N
HT70 PLUS VENTILATOR
MDR report key: 6038889
·
Received October 19, 2016
Report
- Report Number
- 2023050-2016-00627
- Event Type
- Malfunction
- Date Received
- October 19, 2016
- Date of Event
- September 20, 2016
- Report Date
- September 21, 2016
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K111146
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE VENTILATOR WAS RETURNED FOR EVALUATION. WHEN THE SERVICE ENGINEER EVALUATED THE DEVICE, IT WOULD NOT POWER UP ON THE BATTERY. IT DID POWER UP PROPERLY WHILE ON ALTERNATING CURRENT (AC). THE DEVICE REMAINED ATTACHED TO AC POWER OVER NIGHT. WHEN REMOVED FROM AC AFTER AN OVERNIGHT CHARGE, THE DEVICE SHOWED A NORMAL DROP IN BATTERY POWER WHILE UNDER STANDARD SETTINGS. THE POWER PAC AND BACKUP BATTERY WERE REPLACED AS A PRECAUTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SET UP THE HT70 VENTILATOR SCREEN WENT BLANK. ALTHOUGH REQUESTED, INFORMATION REGARDING PATIENT INVOLVEMENT WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 690286 | HT70 PLUS VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |