MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-14 for WALKAWAY-40 SI N/A B1018-240A manufactured by Beckman Coulter.
[70307011]
Beckman coulter field service engineer (fse) evaluated the instrument during service visit. Fse found that the hatch door gas shock was not holding the hatch up. Fse replaced the worn out door spring part number 5601-0070. After replacing the faulty spring, the service hatch door functioned as expected. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70307012]
It was reported that the service hatch door on the walkaway (wa) 40si hit an operator on the head. It was suspected that the door may not have been opened fully causing it to drop slowly until it hit the head of the operator however medical attention was not required. The operator pushed the door all the way up and it seemed to be holding in that position but still had requested service to check it out. It was also reported that the same issue had occurred once before and that the technician did not require medical attention. No report of serious injury and no additional details were provided regarding the previous incident. The customer did not previously report the event to beckman coulter. There was no serious injury reported in connection with this event.
Patient Sequence No: 1, Text Type: D, B5
[72890992]
There was no unique device identifier labeling when the affected instrument was manufactured and installed. The instrument is a class ii device that was manufactured on 11/01/2005 prior to the fda's mandated deadline of 09/24/2016. Beckman coulter identifier for this report is cf170228-146.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2919016-2017-00004 |
| MDR Report Key | 6403623 |
| Date Received | 2017-03-14 |
| Date of Report | 2017-02-28 |
| Date of Event | 2017-02-27 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2017-03-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELIZABETH CHURCH |
| Manufacturer Street | 1584 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal | 95691 |
| Manufacturer Phone | 9163742457 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 2040 ENTERPRISE BLVD |
| Manufacturer City | WEST SACRAMENTO CA 95691 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95691 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKAWAY-40 SI |
| Generic Name | INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPTIBILITY SYSTEM |
| Product Code | LRG |
| Date Received | 2017-03-14 |
| Model Number | N/A |
| Catalog Number | B1018-240A |
| Lot Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 2040 ENTERPRISE BLVD WEST SACRAMENTO CA 95691 US 95691 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-14 |