DORNIER COMPACT DELTA II
Report
- Report Number
- 1037955-2019-00029
- Event Type
- Injury
- Date Received
- July 26, 2019
- Date of Event
- May 29, 2019
- Report Date
- June 28, 2019
- Manufacturer
- DORNIER MEDTECH SYSTEMS GMBH
- Product Code
- LNS
- PMA / PMN Number
- P840008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
AS OF 07/26/2019, THE CUSTOMER HAS NOT YET MADE THE DEVICE AVAILABLE FOR EVALUATION. DORNIER MEDTECH AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH SYSTEMS GMBH (MANUFACTURER) PER EXEMPTION E2012002. FOLLOW UP #1 (B)(6) 2019: A SERVICE REPORT COMPLETED AND DATED 08/05/2019 BY A DMTA DMTA DISTRICT SERVICE MANAGER INDICATED THAT THE DEVICE WAS IN COMPLIANCE WITH DORNIER SPECIFICATIONS. A HEMATOMA IS LISTED AS A POTENTIAL ADVERSE EFFECT AND COMPLICATION IN THE COMPACT DELTA II OPERATING MANUAL. THE DETAILS CONCERNING THE PATIENT OUTCOME WERE NOT MADE KNOW. NO FAULT WITH THE DEVICE AS MANUFACTURED. DEVICE WAS FOUND TO BE FUNCTIONING WITHIN DORNIER SPECIFICATIONS. DMTA REQUESTED ACCESS TO THE SYSTEM FOR A CHECK INITIAL AFTER NOTIFICATION, HOWEVER THE CUSTOMER DID NOT PROVIDE DMTA SERVICE ACCESS TO THE MACHINE UNTIL 08/05/2019.
AS OF 07/26/19, THE CUSTOMER HAS NOT YET MADE THE DEVICE AVAILABLE FOR EVALUATION. DORNIER MEDTECH AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH SYSTEMS GMBH (MANUFACTURER) PER EXEMPTION E2012002.
PATIENT HEMATOMA REPORTED.
PATIENT HEMATOMA REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 627221 | DORNIER COMPACT DELTA II | LITHOTRIPTER | LNS | DORNIER MEDTECH SYSTEMS GMBH | COMPACT DELTA II |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |