FDA Adverse Event
Malfunction
Summary report: N
LIFE-STAT
MDR report key: 14459188
·
Received May 20, 2022
Report
- Report Number
- 1821850-2022-00001
- Event Type
- Malfunction
- Date Received
- May 20, 2022
- Date of Event
- April 25, 2022
- Report Date
- May 19, 2022
- Manufacturer
- MICHIGAN INSTRUMENTS, LLC
- Product Code
- DRM
- PMA / PMN Number
- K073079
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPON RECEIPT, DAMAGE TO UPPER ARM COVER FOUND AS WELL AS SOURCE GAS LEAKAGE FROM THE COLUMN. IMPACT DAMAGE ON CORNERS OF DEVICE NOTED. OPERATION NOTED COMPRESSIONS DELIVERED WITH INTERMITTENT STOPPING AND STARTING. DETERMINED SOLENOID ON TIMING COMPONENT HAD GONE BAD. REPLACED SOLENOID AND DAMAGED COMPONENTS. TESTED AND ACCEPTED TO FACTORY SPECIFICATIONS AND RETURNED TO CUSTOMER.
Description of Event or Problem · 0
DEVICE REPORTED TO BE NON-FUNCTIONAL AND STOPPING WHILE IN USE ON A PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1657681 | LIFE-STAT | EXTERNAL CARDIAC COMPRESSOR | DRM | MICHIGAN INSTRUMENTS, LLC | 1008 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |