MAUDE Adverse Event Report: WELCH ALLYN, INC. VSM6700/SPN/ST/PR/PLUGB; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	67NXTP-B
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cvsm 6700 device was returned to hillrom/welch allyn for investigation.Preliminary investigation by the technician at the account identified that the speaker became disconnected from the main pcb assembly.The device was returned to hillrom/welch allyn engineering for further investigation of the root cause of the alleged malfunction.As per the service manual for the 67nxtp-b, the steps were followed to verify a board-level issue was present.The alarm was triggered as verified by the visual indicator in the message status area and illumination of the light bar.The alarms submenu in the settings menus showed that the alarm audio was enabled, set to adequate volume levels, and advanced settings were checked to make sure the general audio was not turned off by the user.These steps did not resolve the missing audio issue.The next step involved the checking of the connections at the speaker on the main board.It was determined that connector j12 was removed from the board via tension in the cable, which resulted in the audio issue.Because the cable was not merely disconnected from the housing but rather pulled the housing off, the tension in the cable was assumed to be the cause of the separation.The cause for the complaint is that the cable connected to the speaker output was assembled and placed such that there was too much tension and the connector snapped off from the main pcba.This tension resulted from the positioning of the cable as well as the cable tie surrounding the speaker, smart harness and battery cable bundle.As a result, there was no path for the speaker audio to be produced during an alarm.Manufacturing process guidelines were reviewed and note that the cable tie and cable bundle should be oriented such that there is slackness in the wiring.Comparing this setup to how the tied bundle was positioned in the current device, the cable tie in the manufacturing guidelines is tied in a different spot further away from the origin such that there is less tension in the wire.This is the first investigation of this alleged malfunction since hillrom has not received any other complaints with this root cause.Based on this information, no further action is required at this time.
Event or Problem Description
The customer alleged that the unit will not produce sound when an alarm is being displayed on the device.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: VSM6700/SPN/ST/PR/PLUGB
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street road; skaneateles falls NY 13153
• MDR Report Key: 10740266
• Report Number: 1316463-2020-00008
• Device Sequence Number: 3060710
• Product Code: MWI
• UDI-Device Identifier: 00732094151138
• UDI-Public: 732094151138
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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
• Operator of Device: No Information
• Device Model Number: 67NXTP-B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1