MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVE INTERNAL HANDLES; INTERNAL HANDLE (STEM)

Model Number 1011-0141-03-16

Device Problem Failure to Discharge (1169)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that during biomed testing, the device failed to discharge.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.

Manufacturer Narrative

The internal handles were returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty switch on the internal handles.The internal handles were scrapped.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: AUTOCLAVE INTERNAL HANDLES
• Type of Device: INTERNAL HANDLE (STEM)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 6272368
• MDR Text Key: 65908846
• Report Number: 1220908-2017-00060
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1011-0141-03-16
• Device Catalogue Number: 1011-0141-03-16
• Other Device ID Number: 00847946022884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/15/2017; 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1